System and method for peritoneal dialysis exchanges having reusable energizing unit

ABSTRACT

A peritoneal dialysis system includes (i) a fill container, and (ii) an energizing unit that removably accepts the fill container, the energizing unit including a sterilization source so configured and arranged relative to the fill container when accepted by the energizing unit to place fluid within the fill container in a physiologically safe condition for delivery to the peritoneal cavity of a patient.

PRIORITY CLAIM

This application claims priority to and the benefit of (i) U.S.Provisional Application No. 61/917,739, filed Dec. 18, 2013, entitled,“System And Method For Remote Peritoneal Dialysis Exchanges” and (ii)U.S. Provisional Application No. 61/784,562, filed Mar. 14, 2013,entitled, “System And Method For Remote Peritoneal Dialysis Exchanges”,the entire contents of each of which are incorporated herein byreference and relied upon.

BACKGROUND

The present disclosure relates to peritoneal dialysis treatment. Morespecifically, the present disclosure relates to systems and methods ofenabling convenient and inexpensive peritoneal dialysis treatment formultiple patients in a single location.

Many people suffer from renal disease, in which the kidneys do notadequately filter toxins and waste products from the blood. When kidneyfailure occurs, water and minerals become unbalanced in blood andtissues, and toxic end products of nitrogen metabolism (e.g., urea,creatinine, uric acid and others) can accumulate. A person with failedkidneys cannot continue to live without replacing at least thefiltration functions of the kidneys.

Different forms of dialysis treatment are used to treat patientssuffering from renal disease. One form of dialysis treatment ishemodialysis, in which the patient's blood is passed through anartificial kidney dialysis machine and cleansed before reentering thepatient. Because hemodialysis is an extracorporeal procedure, there arecertain limitations associated with the treatment. For example,treatment typically lasts several hours and is generally performed in atreatment center about three times per week.

A second form of dialysis treatment is peritoneal dialysis, in which thepatient's own peritoneum is used as a semi-permeable membrane ratherthan an artificial kidney. One advantage to peritoneal dialysis is thatpatients can undertake treatment at home instead of visiting a medicalfacility or utilizing costly equipment associated with hemodialysistreatment.

When a patient undergoes peritoneal dialysis treatment, a dialysissolution is periodically infused into the peritoneum through animplanted catheter. Diffusion and osmosis exchanges take place betweenthe dialysis solution and the bloodstream across the natural bodymembranes, which remove the water, toxins and waste products that thekidneys normally excrete. After a period of time, the used dialysissolution is drained from the peritoneum and replaced with fresh fluid.The period of time that the dialysis solution remains in the patient'speritoneum is referred to as the dwell time.

There are generally two types of peritoneal dialysis treatment:automated peritoneal dialysis (“APD”) and continuous ambulatoryperitoneal dialysis (“CAPD”). APD uses a dialysis machine to drain, filland dwell dialysis solution from the peritoneum through an implantedcatheter. Several drain, fill, and dwell cycles normally occur while thepatient is connected to the dialysis machine. The main advantage of APDis that it is hands-free regarding the patient and can therefore beperformed at night while the patient is asleep, freeing the patientduring the day.

With CAPD, a dialysis solution is manually introduced into theperitoneum through an implanted catheter. During the dwell time, anexchange of solutes between the dialysis solution and the blood isachieved. Once this exchange is achieved, the patient manually drainsthe dialysis solution from the peritoneum and manually replaces thedrained solution with fresh fluid. This process is repeated per adoctor's prescription. One advantage to CAPD is that patients do notneed a machine as gravity is used to fill and drain the patient.

Regardless of whether the patient performs APD or CAPD, the patient'sprescription may call for a midday exchange. During a midday exchange,the patient drains used dialysate from the patient's peritoneum andfills the peritoneum with a fresh supply of dialysate. The middayexchange can be cumbersome especially for a patient at work. If thepatient cannot return home, then the patient has to find a place at workto perform the procedure. The solution and disposables needed to performthe procedure also need to be available at work. The transfer andstorage of the materials and the procedure may be awkward orembarrassing for the patient.

A need exists accordingly for an improved peritoneal dialysis treatment,especially for single exchanges, such as midday exchanges.

SUMMARY

The present disclosure seeks to solve these and other needs by providinga system and method to enable multiple patients to receive a peritonealdialysis treatment at a remote location such that the patients do nothave to store fresh dialysis solution or related supplies at home orwork. The present system and method are useful for example for patientsthat do not have time to return home to perform dialysis treatmentduring the day. The system and method are useful for patients indeveloping countries and low income areas that do not have access to orthe means to have dedicated home dialysis equipment. The system andmethod also provide effective peritoneal dialysis treatment to numerouspatients in a convenient and cost effective manner. For example, thesystem and method can be used by a patient with a hectic work or dailyschedule, allowing the patient to stop off at a facility according tothe present disclosure on the way to or from work, during work, orduring or in conjunction with other daily activities. A busy patient canuse home equipment in combination with a facility according to thepresent disclosure to optimize his or her time, for example, by stoppingat a facility for a fill (or drain and fill) session and then performinga subsequent drain (or drain and fill) session upon returning home atsome time later.

The system and method include a facility. The facility includes aplurality of peritoneal dialysis treatment stations or rooms. Eachtreatment station or room is capable of performing one or moreperitoneal dialysis patient exchange. It is contemplated to provide thedialysis stations or rooms with electrical and/or entertainmentequipment, such as televisions, computers, headphones, tablets, Internetaccess, and the like, so that the patient can be entertained or performwork during the exchange, and possibly over an extended period if thepatient performs multiple exchanges. Thus, a patient may leave work, goto the facility, and perform an exchange while logging into thepatient's internal work website to continue work.

A facility can be located alternatively at a worksite, so that patientscan conveniently receive treatment before, during or after work withoutdisrupting their work schedules. A facility can further alternatively belocated within or nearby a housing unit, at a train station, bus stationor airport, or at a hostel or other temporary dwelling location, forexample, to allow residents of the unit or dwelling to receiveconvenient treatment without having to own their own dialysis equipmentor store their own disposable supplies. Such a facility is especiallyuseful in developing countries in which most residents do not have themeans for or access to dedicated home dialysis equipment. Certaincountries, for example in Asia, provide temporary dwelling locationsnear work, so that employees can live near work during the week andreturn home on the weekend. The facilities of the present disclosure canbe located at or near any such temporary dwelling locations.

It is contemplated for each facility to have a front desk or entry area.Patient visits to the facility can be by appointment and/or allow forwalk-in business. The patient in an embodiment carries a computerreadable medium having the patient's therapy prescription or otherpatient identification that allows the patient's prescription to beverified. Once verified, the patient is allowed into a treatment area ofthe facility, connected to a correct type of filling apparatus, e.g.,batch or bagged, and provided with prescribed disposable supplies. Thepatient then proceeds to a designated exchange station, which may becovered by, e.g., curtains or cubicle dividers.

The exchange stations can include an automated peritoneal dialysis(“APD”) machine, such as a HomeChoice™ or HomeChoicePro™ machineprovided by the assignee of the present disclosure. The stations canalternatively be configured to provide a continuous ambulatoryperitoneal dialysis (“CAPD”) treatment. In an embodiment, the facilityprovides both in-center APD and CAPD stations to meet the needs of anyoperational dialysis prescription.

Both APD and CAPD treatments use a disposable set. The APD disposableset typically involves a disposable pumping cassette that is coupled toand operated by an APD machine. A plurality of tubes are connected tothe disposable cassette. The tubes connect to the patient, a drain, andto one or more supply bag of peritoneal dialysis solution or dialysate.The CAPD disposable set is typically simpler because the set does notneed to interact with a machine. The set includes a plurality of tubesfor connecting to the patient, the drain, and one or more dialysis fluidsupply. The set may use a manually operated valve to switch betweencycles or instead use manual pinch clamps.

The patient whether using bagged solution or batch solution is providedwith the correct amount and type of dialysis solution. In a CAPDtreatment, once the patient enters the treatment area, the patientmanually drains his or her effluent dialysis fluid, and then manuallyfills his or her peritoneum with dialysis solution provided by thefacility. In an in-center APD treatment, the patient proceeds to adesignated dialysis machine. The patient is provided with a cassette forthe machine, which is loaded into the machine to perform one or moreautomatic exchanges.

The drain at each facility can include a large community or house drain.The community or house drain allows multiple patients to quickly drainto a common tank or basin. Structure and methodology are provided toensure sterile connection to and disconnection from the common drain,which is also the case with large dialysate storage vessels ormulti-treatment fill containers discussed in detail below. For example,the treatment area can provide sterilization units (e.g., UV-radiation)or sterilization agents (e.g., rubbing alcohol) for sterile connection.The treatment areas may also provide weigh scales, blood pressure cuffsand sample collection bags and associated analyzers, which may all beused to enhance treatment and patient care.

The patient can alternatively drain into a single patient draincontainer or bag. In either of the community or single drain containersituations, it is contemplated to enable a sample of the patient'seffluent to be taken. It is expressly contemplated for the facility toperform onsite effluent analysis if the patient desires and/or if thepatient's prescription calls for an effluent analysis to be performed.The facility's house drain complies with any regulations regarding thedisposal of biowaste. Likewise, the facility is equipped to properlydispose of the effluent waste containers and the used disposablecassettes and sets.

Alternatively, instead of discarding the used dialysate, a portion orall of the effluent dialysate may be regenerated into useable dialysate,e.g., using a sorbent system. The sorbent system removes undesirablecomponents from effluent dialysate absorbed from the patient (e.g.,toxins, fibrin and metabolic wastes), so that the dialysate can be usedagain. The sorbent system can also add desirable components (e.g.,dextrose, glucose, and/or salts) to the regenerated dialysate toreconstitute the dialysate and to maintain a desired osmotic gradientfor ultrafiltration removal. Using a sorbent system to clean theeffluent dialysate collected by the facility enables the facility toreduce the amount of fresh dialysate that must be ordered and stored.For example, a single patient can use several hundred liters of freshdialysate every month, so even a small facility serving only one-hundredpatients can reduce its inventory of fresh dialysate by thousands ofliters per month if the facility has a sorbent system in place toregenerate used dialysate. Using a sorbent system to clean the effluentdialysate collected by the facility also reduces the amount of usedfluid that is discarded to the environment.

Alternatively or in addition to sorbent regeneration, other forms ofeffluent cleaning for regeneration may be used, such as any one or moreof electrodialysis (“ED”), electrodialysis reversal (“EDR”),electrodeionization (“EDI”), ultrafiltration, reverse osmosis filtering,ultraviolet radiation, or ozone. Ozone can be created online bysubjecting oxygen to ultraviolet light. The ozone can then be drawn intothe effluent stream, e.g., via a venture pump. Ozone tends not to storewell under positive pressure.

The dialysis solution or dialysate can be bagged or be stored in a largestorage vessel. Dialysate used at home or at work is typically bagged,and it is contemplated to use bagged dialysate at the facilities of thepresent disclosure. Alternatively or additionally, the dialysate can bestored in a large vessel that is common to multiple patients. Thedialysates are provided in different varieties, e.g., have differentdextrose and glucose levels, and are set for each individual patient pertheir prescription. A midday exchange may, for example, use a differentdialysate than the patient's prescribed nighttime dialysate. It isaccordingly contemplated to provide different vessels having dialysateswith different glucose or dextrose levels.

The vessels may each have a plurality of outlets, which each connect toa different patient line, e.g., for gravity delivery. It is contemplatedto place an ultraviolet (“UV”) lamp about each outlet so that each newconnection is sterilized before any fluid is allowed to flow to thepatient. The UV lamps can be in the form of clamshells that open toallow connection and disconnection. After connection, the clamshells areclosed and the connection is UV sterilized. The connections canalternatively or additionally be sterilized by other methods, forexample, through the use of hydrogen peroxide vapor, gamma irradiation,peracetic acid, ethylene oxide, ethanol, formalin, glutaraldehyde, lowenergy electron beam and/or any other sterilization method known in theart. For safety, some of these sterilization methods may be performed ina room segregated from the patients.

Various embodiments herein are targeted for countries that do not havemedical reimbursement, and in which patient's needing dialysistreatments may not be able to afford treatment. One major goal here isto reduce the amount of disposable waste and thus disposable cost asmuch as possible. One good way to reduce the amount of disposable wasteis to refurbish and reuse components that touch fresh and spent dialysisfluid. Thus in multiple embodiments discussed below, a reusable draincontainer is provided. The reusable drain container is portable. Thepatient receives a dry, disinfected drain container upon entering thefacility and returns the drain container filled with effluent fluidafter a remote exchange has taken place.

In one implementation, the reusable drain container is coupled with afilled, sterilized and heated fill container and a reusable CAPD set.The patient receives all three reusable units upon entering thefacility, transports same to a patient station, performs a remote PDexchange, and brings the used units back to the front desk of thefacility for refurbishment. The patient may receive a deposit back forreturning the units if a deposit is required to receive the units.

Each of the three units is then refurbished. In one embodiment, some orall of the drain container, fill container and CAPD set are sent to anoffsite, e.g., central, location for disinfection, sterilization and forre-loading the fill container with sterilized dialysate. Alternatively,the drain container may be disinfected at the treatment facility. It iscontemplated in this first implementation, however, that the equipmentused to prepare and sterilize the dialysate and the fluid be locatedoffsite, and that the facility maintain a minimal amount of equipment.For example, the facility may only need a larger warmer to warm thefilled reusable fill containers and perhaps a hot water disinfectionbath or unit to disinfect the reusable drain containers if merelydisinfecting of the drain container (as opposed to sterilization) isacceptable. The majority of the refurbishing is done offsite with usedunits being shipped out of and refurbished units being shipped into thetreatment facility daily.

It is further contemplated to provide a pouch that holds the CAPD set.The pouch releasably snaps onto the reusable drain container forshipment. The CAPD set may be configured to have three tubing legs, onerunning to the patient, a second leg running to the fill container, anda third leg running to the drain container. The three legs meet at ajunction. A manual flow control device is provided at the junction toallow the patient to switch from a drain phase or sequence, to a flushphase or sequence (for priming), and then to a patient fill phase orsequence. The CAPD set may be configured alternatively to be a singleline. Here, the patient connects the single line first to the patientand the drain container to perform a patient drain. The patient thendisconnects the line from the drain container and reconnects the sameend of the line to a fill container. The patient then performs a patientfill, perhaps needing to prime the patient line first by venting airthrough a hydrophobic vent provided in the single line CAPD set.

The single line CAPD set may be easier to disinfect and sterilize thanthe three-legged CAPD set. The drain line in particular may becomefilled with fibrin and other patient particulates. The single line CAPDset may be more easily flushed of such particulates. Also, thereconnection of the single line APD set to the patient for filling maypush some of the particulates back to the patient prior to the end ofpatient fill, eliminating the need to remove those particles after theremote exchange is completed. Nevertheless, it is contemplated that thethree-legged APD set can also be properly cleared of patientparticulates and subsequently disinfected.

In another implementation, the reusable drain container is coupled witha permanent or semi-permanent filling system. That is, each CAPD patientstation of a treatment facility is provided with a filling system thatis mounted in place and is not transported back and forth to and fromthe front desk of the treatment facility. The filling system includes anenergizing unit and a fill container. The fill container resides withinthe energizing unit and remains within the unit until it needs to beremoved for cleaning, replacement or for some other infrequent purpose.The energizing unit is open along at least one surface so that the fillcontainer can be easily removed from the unit. The energizing unitincludes a control unit that controls a plurality of valves and recordsreadings from a plurality of sensors. The valves and sensors aretethered to the energizing unit via electrical wiring, so that they canbe moved and releasably coupled to the fill container during normal useand removed from the fill container when the container needs to beremoved from the energizing unit for whatever reason. The valves pinchclose or unpinch open tubing leading to and from the fill container toperform container fills and container dispenses. The sensors provideneeded feedback to the control unit, such as liquid temperature andconductivity feedback.

The energizing unit in one embodiment includes a weigh scale thatrecords how much liquid is delivered to and how much dialysate isdispensed from the fill container. The energizing unit includes otheractuators depending upon what is needed. For example, if the liquidprovided to the fill container is not sufficiently sterile, theenergizing unit is equipped with a plurality of ultraviolet (“UV”)lights that irradiate the liquid to perform the needed remainingsterilization. If the liquid provided to the fill container is notheated to body temperature, the energizing unit is provided with one ormore heating coil that heats the liquid to a proper temperature. If theliquid provided to the fill container is purified water instead ofdialysate, the fill container is provided with a removable cap to acceptdialysate additives, e.g., granulated or powderized additives. Theenergizing unit's conductivity sensors send a signal to its control unitto confirm that the additive has been mixed with the proper volume ofwater. The additive can be provided in a tear-open packet.

A separate sterilizing unit can be provided in addition to the permanentor semi-permanent filling system. The sterilizing unit is used toprovide any additional sterilization needed for the CAPD sets at thepoint and time of use. Either of the three-legged or single line CAPDsets can be used with the filling system and the sterilizing unit. Thesterilizing unit can in turn be used with any embodiment describedherein requiring PD set sterilization.

The sterilization unit in one embodiment includes a clamshell or hingedarrangement with a base and a lid. The base and lid are each providedwith UV lights that irradiate and sterilize the CAPD sets. The patientsets the CAPD set into the base, closes the lid and presses a switch orbutton to begin the sterilization. In one embodiment, the UV irradiationtakes place for a preset amount of time known to sterilize the CAPD setin a worse case scenario and then shuts down automatically. The patientcan immediately remove the CAPD set for use. The sterilization unit'sirradiation in combination with between-exchange disinfection (e.g., viahot water bath) eliminates the need for the CAPD set to be packaged in asterilized bag, reducing disposable waste. The CAPD sets are reused,further reducing disposable waste.

The filling system, reused fill container, reused drain container andsterilization unit enable the treatment facility to be self-contained,that is, to not require shipments to or from a refurbishment center. Thetreatment facility in one embodiment need only have one or more backroomwater purification unit, a backroom hot water bath disinfection systemor unit and perhaps a backroom pre-heater for use in combination withthe localized patient station filling systems and sterilization units.The only waste produced in one embodiment is the packet used to hold thegranulated or powdered dialysate additives.

The systems and methods herein enable the patient to alternate between ahome treatment and treatment at one or more peritoneal dialysisfacility. The home treatment can be a PD treatment or a blood treatment,such as hemodialysis (“HD”). It has been proposed that a combination HDand PD regimen is beneficial. The PD facility may also be moreconvenient for an HD patient who is traveling on work or business.

One or more server computer can be connected over a web portal to thepatient's home equipment and the various facilities to store datarelated to the patient's at home and in-facility treatments in anelectronic medical record database. The database can be accessed eachtime the patient needs treatment to verify the parameters of thepatient's prescription, and/or to verify or allow the patient to receivetreatment at the facility. Thus, the patient may not need to carry acomputer readable medium. The patient can instead be recorded to andlocated on the system. The system also allows the patient's physician toaccess and alter the patient's treatment. The patient's home equipmentand the various facilities can both immediately receive that updatedinformation and adjust the patient's treatment accordingly.

It should be appreciated however that the system does not have to beserver based. Instead, the facility can use a computer for accepting andverifying a patient's prescription, e.g., via a flash drive or computerstick, and identify the patient's prescribed solution type and volume.This alternative facility can be used in developing countries and otherareas in which a server based system and website is not feasible. Indeveloping countries, some or all of the peristaltic treatment can beperformed at a facility.

The present system and method allow the patient to receive convenientperitoneal dialysis treatment without having to return home throughoutthe day. The system and method can free the patient from having to storelarge quantities of dialysis solution at his or her home assuming, forexample, that the patient performs all or most of all peritonealdialysis exchanges at one of the treatment facilities of the presentdisclosure. If several treatment facilities are located throughout thepatient's town or city of residence, the patient can likely findconvenient access to peritoneal dialysis treatment regardless of what heor she has to do on a given day.

It is accordingly an advantage of the present disclosure to provide asystem and method for performing remote peritoneal dialysis exchanges.

It is another advantage of the present disclosure to provide a systemand method for providing convenient peritoneal dialysis exchanges.

It is a further advantage of the present disclosure to provide a systemand method for performing peritoneal dialysis exchanges in combinationwith home peritoneal dialysis treatments.

It is yet another advantage of the present disclosure to provide asystem and method for communicating treatment data from a remoteperitoneal dialysis exchange facility to a patient's clinic or hospital.

It is yet a further advantage of the present disclosure to provide asystem and method for providing remote peritoneal dialysis exchanges inwhich there are multiple, selectable ways of providing treatment.

It is still another advantage of the present disclosure to provide asystem and method for providing remote peritoneal dialysis exchanges ina manner that reduces disposable waste.

It is still a further advantage of the present disclosure to provide asystem and method for performing remote peritoneal dialysis exchanges ina safe and sterile manner.

Further still, it is an advantage of the present disclosure to provide asystem and method for providing remote peritoneal dialysis exchangesthat reuse dialysis fluid and/or make dialysis fluid online.

Still further, it is an advantage of the present disclosure to provide aperitoneal dialysis system and method that produces very littledisposable waste or cost.

Still another advantage of the present disclosure is to provideperitoneal dialysis filling units and sterilization units that sterilizethe treatment fluid and treatment sets at the point and time of use.

Still a further advantage of the present disclosure is to providereusable fill containers, drain containers and CAPD sets that can berefurbished for reuse.

Additional features and advantages are described herein, and will beapparent from the following Detailed Description and Figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment for locating a peritonealdialysis exchange facility of the present disclosure.

FIG. 2 is a perspective view of another embodiment for locating aperitoneal dialysis exchange facility of the present disclosure.

FIG. 3 is a perspective view of one embodiment for initiating atreatment session once a patient enters a peritoneal dialysis exchangefacility of the present disclosure.

FIG. 4 is a perspective view of one embodiment for structuring a batchtreatment area of an exchange facility of the present disclosure.

FIG. 5 is a perspective view of one embodiment for structuring a batchor a continuous ambulatory peritoneal dialysis (“CAPD”) treatment areaof an exchange facility of the present disclosure.

FIG. 6A is a perspective view of one embodiment for structuring areusable supply and drain container system for a CAPD treatment area ofan exchange facility of the present disclosure.

FIG. 6B is a plan view of one embodiment of a CAPD set useable with thereusable supply and drain container system of FIG. 6A.

FIG. 6C is a perspective view of the system of FIG. 6A shown in use atone embodiment of a CAPD treatment area of an exchange facility of thepresent disclosure.

FIG. 6D is a schematic view illustrating one embodiment for cleaning andrefurbishing the reusable supply and drain container system and the CAPDset of FIGS. 6A and 6B using a hub and spoke facility arrangement.

FIG. 7A is a perspective view of one embodiment of a CAPD treatment areaof an exchange facility of the present disclosure undergoing a patientdrain procedure using the reusable supply and drain container system ofFIG. 6A with an alternative two-way CAPD set.

FIG. 7B is a perspective view of one embodiment of a CAPD treatment areaof an exchange facility of the present disclosure undergoing a patientfill procedure using the reusable supply and drain container system ofFIG. 6A with an alternative two-way CAPD set.

FIG. 8A is a perspective view of a CAPD treatment area of an exchangefacility of the present disclosure using one embodiment of a permanentor semi-permanent filling system.

FIG. 8B is a perspective view of one embodiment of a permanent orsemi-permanent filling system useable in the system of FIG. 8A.

FIG. 8C is a perspective view of one embodiment of a fill containeruseable with the permanent or semi-permanent filling system of FIGS. 8Aand 8B.

FIG. 8D is a perspective view of one embodiment of an energizing unituseable with the permanent or semi-permanent filling system of FIGS. 8Aand 8B.

FIG. 8E is a top plan view of one embodiment of an energizing unituseable with the permanent or semi-permanent filling system of FIGS. 8Aand 8B.

FIG. 8F is a perspective view of one embodiment of a sterilizing unituseable with the permanent or semi-permanent filling system of FIGS. 8Aand 8B and any of the of the other system embodiments discussed herein.

FIG. 8G is a perspective view of one embodiment for a packet containingdialysate additives, which when mixed with a defined volume of waterproduce chemically balanced dialysate.

FIG. 9 is a perspective view of one embodiment for structuring anautomated peritoneal dialysis (“APD”) treatment area of an exchangefacility of the present disclosure.

FIG. 10 is a plan view of one embodiment of a peritoneal dialysisexchange facility according to the present disclosure.

FIG. 11 is a perspective view for one embodiment of a batch peritonealdialysis treatment area of a peritoneal dialysis exchange facilityaccording to the present disclosure.

FIG. 12 is a plan view of one embodiment for an automated peritonealdialysis (“APD”) machine treatment area of a peritoneal dialysisexchange facility according to the present disclosure.

FIG. 13 is a plan view of one embodiment for a continuous ambulatoryperitoneal dialysis (“CAPD”) machine treatment area of a peritonealdialysis exchange facility according to the present disclosure.

FIG. 14 is a schematic block diagram of one embodiment for a systemaccording to the present disclosure.

FIG. 15 is a schematic block diagram of another embodiment for a systemaccording to the present disclosure.

DETAILED DESCRIPTION Treatment Facility Locations

Referring now to the drawings and in particular to FIG. 1, oneembodiment for locating a treatment facility 100 of the presentdisclosure is illustrated. It is contemplated to place treatmentfacility 100 in a large city and on a busy street 12, in which there isa large amount of travel of pedestrians 14, including one or moredialysis patient 16. Patients 16 can be strictly peritoneal dialysis(“PD”) patients. It is contemplated however that if a doctor orclinician agrees, a patient who typically undergoes hemodialysis (“HD”),hemofiltration (“HF”) or hemodiafiltration (“HDF”) could also performone or more PD exchange at facility 100. For example, a patient 16traveling on business or vacation can perform a PD treatment at afacility 100 in place of the patient's normal treatment if it is moreconvenient to do so.

Street 12 in the illustrated embodiment is a busy street with muchsidewalk traffic, providing a high amount of visibility to facility 100.In FIG. 1, treatment facility 100 is the sole business residing within abuilding 20 bounded by buildings 22 and 24. Facility 100 couldalternatively be one of many businesses housed inside a larger buildingor sky rise, such as building 22 or 24. Street 12 can be a busy citystreet as illustrated or a suburban street or drive, for example, at amall, strip mall, business park, or another high visibility location.Facility 100 can be located at or near a hospital, medical center ordoctor's office if desired. Facility 100 can be marked clearly asillustrated in FIG. 1 or be generically adorned for discrete entry andexit.

As discussed additionally in connection with FIG. 10, facility 100includes a door 102 through which patients 16 enter and exit. Door 102can be located on the outside of facility 100 as illustrated or belocated inside of the building, down a hallway and on any floor of abuilding, such as a building full of doctor's offices. Door 102 can beopened freely by any pedestrian 14 or patient 16, or if desired, door102 can be locked and provided with an automatic opener that patient 16opens by sliding a card, or which is opened electronically by a personworking inside of facility 100 upon the appearance of or door bell ringby patient 16.

Referring now to FIG. 2, facility 100 is located alternatively inside ofa building, here a train station or depot. It is expressly contemplatedto place facilities 100 of the present disclosure at places of masstransit, such as train stations, bus stations, airports and the like, sothat patients arriving at the location or departing from the locationcan perform one or more dialysis exchange upon arriving at the location,e.g., before heading to work, or before departing on a train, bus orairplane, etc., e.g., after work or before a long trip.

Certain countries have temporary dwelling or sleeping facilities thatworkers use during the week before returning home on the weekend. It isexpressly contemplated to place facilities 100 at such locations or athostels, hotels, nursing homes or condominium complexes. It is alsoexpressly contemplated to place PD exchange facilities 100 at places ofwork, such as at a large factory or at a central location within anindustrial park, so that people at work can take an hour or so toperform one or more dialysis exchange either before, during or afterwork (e.g., a midday exchange).

Treatment Facility Configurations

Referring now to FIG. 3, and as shown in conjunction with FIG. 10, oncepatient 16 enters facility through door 102, the patient encounters adesk 104 in one embodiment, and is able to speak with a facilityprofessional 18 manning a computer 106 a or 106 b, smart tablet 106 c,or some combination thereof. The interaction between patient 16 andfacility professional 18 is described in more detail below in connectionwith FIGS. 10, 14 and 15, but generally the interaction is one in whichfacility professional 18 validates patient 16 and verifies that thepatient is authorized, e.g., prescribed to, receive treatment atfacility 100, and if so identifies the type of and parameters for thetreatment. In the illustrated embodiment, patient 16 hands facilityprofessional 18 a smart card, memory stick, flash drive or the like 26,which facility professional 18 inserts into or otherwise electronicallyconnects to computers 106 a, 106 b, tablet 106 c or some combinationthereof. It is also contemplated to allow patient 16 to show a barcodeor other marking using the patient's smart phone or tablet, whichfacility professional 18 visually scans at desk 104. Other structure andfunctionality for authorizing and/or verifying patient 16 is discussedbelow.

Referring now to FIG. 4, a large batch tank CAPD system is illustrated.Here, once patient 16 is authorized or verified at desk 104, patient 16is allowed to enter a treatment area of facility 100. FIG. 4 illustratesone embodiment in which patient 16 receives dialysis fluid from a largerdialysis batch solution tank 210. Treatments involving larger dialysisbatch solution tanks 210 are discussed in detail below in connectionwith FIGS. 10 and 11. For now, it is important to know that multiplepatients 16 can perform exchanges simultaneously using a single largerdialysis solution tank 210.

In the illustrated embodiment, larger dialysis solution tank 210 is usedas a hub from which a plurality of walls 32 a to 32 d extend to form aplurality of individual and semi-private patient stations 30 a to 30 d.More or less than four walls and patient stations may be formed for agiven hub tank 210. Multiple hub tanks 210, each having separation wallsand corresponding patient stations may be located behind the desk area104 of a given facility 100. Although not illustrated, patient stations30 a to 30 d may be enclosed by a curtain, wall and/or door, forexample.

In the illustrated embodiment, each patient station 30 a to 30 dincludes a chair, sofa, bed, or the like 34, which allows the patient torest comfortably during the one or more PD exchange. The opposing wallfrom the wall against which chair, sofa, or bed 34 is placed can have atelevision or computer monitor 36 to provide entertainment and/orinformation to patient 16 during the one or more PD exchange. Television36 is controlled via a remote control 38, which can be set on and/orstored in a desk or table 40, and which can all be provided in eachpatient station 30 a to 30 d in the illustrated embodiment. One or morewall outlet 42 can be provided for each patient station 30 a to 30 d topower the patient's personal computer, smart phone, tablet, combinationcomputer/tablet, compact disk player, digital music player, portabletelevision, and the like.

In the illustrated embodiment, each patient 16 at one of the patientstations 30 a to 30 d receives PD treatment fluid from larger dialysissolution tank 210 via a patient line 50. FIGS. 10 and 11 discuss indetail how PD treatment fluid can be metered through a dispenser 220 a,220 b, etc., which acts as or replaces patient line 50 in FIG. 4. FIGS.10 and 11 also discuss various ways in which patient 16 receivingtreatment via larger dialysis solution tank 210 can drain effluentdialysate before a first PD exchange or between multiple PD exchanges.

Referring now to FIG. 5, one bagged CAPD embodiment is illustrated. Oncepatient 16 is authorized or verified at desk 104, patient 16 is allowedto proceed to an alternative treatment facility 100, in which PDtreatment fluid is fed initially to a patient bag 52 and then frompatient bag 52, through patient line 50, to patient 16. In FIG. 5,alternative patient stations 60 a to 60 c (any number of which can beprovided), divided by walls 62 a to 62 d, are horizontally juxtaposed asopposed to being laid out in a circular manner as is illustrated in FIG.5. Any of the horizontal, circular or other geometrical patient stationarrangements discussed herein can be used with any type of the PD fluiddelivery mechanism (e.g., bagged, batch or online) discussed hereinand/or with any type of effluent PD fluid draining mechanism (e.g.,bagged or community drain) discussed herein.

Horizontally juxtaposed patient stations 60 a to 60 c can have any one,or more, or all of chair, sofa, bed, or the like 34, television 36,remote control 38, desk or table 40, and/or alternating current walloutlet 42 discussed above in connection with FIG. 4. Stations 60 a to 60c can likewise be closed by a curtain, wall and/or door.

In the PD exchange embodiment of FIG. 5, patients 16 each drain to theirown drain bag 54, e.g., to begin a first PD solution exchange or betweenmultiple patient fills performed at facility 100. As discussed herein,patient drains may be to individual bags, such as bags 54, or to acommon drain. Patient bags 52 are placed on a warmer 55, which may alsobe provided with a weigh scale 56 to weigh any one, or more, or all offresh PD fluid delivered to patient 16, spent PD fluid removed frompatient 16, and additional ultrafiltrate (“UF”) fluid removed from thepatient. UF can be determined for example by subtracting the totalweight of fresh fluid delivered to patient 16 from the total weight ofspent fluid removed from patient 16.

FIG. 5 introduces another feature of the present disclosure discussed indetail below, namely, that facility 100 can provide different types ofdialysates for different patients 16 or for different times during aparticular treatment. In FIG. 4, for example, different larger dialysissolution tanks 210 can hold dialysates of different dextrose or glucoselevels. Likewise in FIG. 5, patient stations 60 a and 60 b are dedicatedto patients receiving DIANEAL™ PD solution, while patient station 60 cis dedicated to patients receiving EXTRANEAL™ PD solution. DIANEAL™ PDsolution and EXTRANEAL™ PD solution are both marketed by the assignee ofthe present disclosure.

FIG. 5 illustrates that a manifold line 64 runs behind patient stations60 a to 60 d, from a DIANEAL™ PD solution source, such as a largerdialysis solution tank 210, to solution lines 68 located inside patientstations 60 a and 60 b. A second manifold line 66 runs behind patientstations 60 a to 60 c, from an EXTRANEAL™ solution source, such as alarger dialysis solution tank 210, to a solution line 68 located insidepatient station 60 c. Patients 16 or a facility professionals 18 (FIG.3) can connect solution lines 68 to fill ports 72 on patient bags 52using valved connectors 70 when patient 16 first arrives at one ofpatient stations 60 a to 60 c. Once bags 52 are filled, valvedconnectors 70 are removed from fill ports 72 on patient bags 52.Patients 16 can then fill themselves from bags 52 whenever they areready, e.g., by using a valve on the patient's transfer set, a valve onthe patient end of patient line 50, and or by opening one or more pinchclamp (not illustrated) placed on patient line 50.

Please note that patient line 50, patient bag 52 and drain bag 54 form astructure similar to a continuous ambulatory peritoneal dialysis(“CAPD”) disposable set 412 discussed below in connection with FIGS. 10and 13. Indeed, CAPD could be performed using sets 412 in the patientstations 60 a to 60 c of FIG. 5 instead of the illustrated batchdialysis, which uses manifold lines 64 and 66.

As long as valved connectors 70 can be repeatedly aseptically connectedto fill ports 72 on the patient bags 52, the patient bags can be usedmultiple times during a visit by patient 16. Patient 16 may accordinglyfill multiple drain bags 54. In an embodiment, patient 16 or facilityprofessional 18 (FIG. 3) removes patient bag 52 from scale 56 at the endof the patient's exchanges and places the one or more drain bag 54sequentially or in combination on weigh scale 56 to record the patient'stotal drain weight. The patient's total fill weight is recorded prior toremoving patient bag 52. The patient's in-session UF can thus becalculated by subtracting total fill weight from total drain weight.Different ways for recording and monitoring patient data produced atfacilities 100 is discussed below.

Referring now to FIG. 6A, a CAPD embodiment using a CAPD unit 140 thateliminates disposables is illustrated. In certain countries, patientsare not reimbursed for dialysis treatments. It is especially importantin such cases to keep costs low. One way of doing so is to reduce oreliminate disposable waste. Reusing and re-sterilizing components savesmaterial costs and any costs associated with having to dispose of apotential biohazard. CAPD unit 140 is shown in an assembled form, whichcan be easily transported. CAPD unit 140 includes a reusable fillcontainer 142 and a reusable drain container 160. Reusable fillcontainer 142 and reusable drain container 160 can be made of the sameor different materials and are made of a semi-rigid or rigid plastic inone embodiment.

In one embodiment, fill container 142 and drain container 160 areplastic, such as polypropylene (“PP”), high density polyethylene(“HDPE”), low density Polyethylene (“LDPE”), polycarbonate (“PC”),glycol-modified polyethylene terephthalate (“PET-G”), polyvinyl chloride(“PVC”), and combinations thereof. Fill container can alternatively oradditionally be stainless steel, such as 316 stainless steel. Draincontainer 160 a can alternatively or additionally be stainless steel oraluminum. Containers 142 and 160 in various embodiments have wallthicknesses, which are generally uniform, and which can be from about 1mm to about 7 mm, e.g., about 4 mm. Containers 142 and 160 defineinternal volumes that are sized for single exchange operation in oneembodiment, e.g., can therefore be configured to hold from about one toabout three liters of fresh PD dialysate or patient effluent fluid.

Reusable fill container 142 is in one embodiment made of a material thatcan be re-sterilized via a suitable process, such as, ultraviolet (“UV”)energy, hydrogen peroxide vapor, gamma irradiation, peracetic acid,ethylene oxide, ethanol, formalin, glutaraldehyde, low energy electronbeam and/or any combination of same. Although reusable drain container160 can likewise be sterilized, it may be sufficient to merely disinfectrather than sterilize reusable drain container 160, e.g., via hot wateror steam disinfection.

Reusable fill container 142 in the illustrated embodiment includes a topwall 144, a bottom wall (not visible), sidewalls 146, a front wall 148and a back wall (not visible). For transportation, as illustrated inFIG. 6A, reusable fill container 142 is laid on its side. Reusable fillcontainer 142 can have a generally rectangular, six-sided shape asillustrated, or have rounded sides, oblong sides and more or less thansix sides or surfaces. Front wall 148 is provided with a label 151,which can be a separate label or be molded permanently into front wall.Label 151 includes information such as solution type (e.g., tradename),solution volume, and solution composition, e.g., dextrose level, glucoselevel, bicarbonate and/or electrolyte level.

Front wall 148 also includes a filling spout 152, which has a manualon/off valve 154 and is fitted with a cap 156 a. Cap 156 a can be athreaded cap, e.g., luer cap, that threads onto a threaded end of spout152. Cap 156 a is not required to seal the entire weight of the PDsolution, however, because valve 154 when in the closed state preventsPD solution from flowing out of reusable fill container 142. Cap 156 adoes however prevent a free-flow situation if valve 154 is openedinadvertently. Cap 156 a also maintains the threaded end of spout 152 ina sterilized condition.

Filling spout 152 can also be provided with a one-way check valve (notillustrated), such as a duck-billed check valve, to prevent PD solutionthat has left reusable fill container 142 from returning to thecontainer. The check valve can have a small cracking pressure, such as0.5 psig or less. Although not viewable in FIG. 6A, reusable fillcontainer 142, e.g., at its rear or top wall or surface, can be providedwith a drain port that is selectively opened to better allow anyresidual PD solution to be poured from the container, and/or to allow asterilizing fluid or substance to be flushed through fill container 142.Or, as illustrated, top wall 144 can be provided with a hydrophobic vent145. Vent 145 helps reusable fill container 142 to be filled, e.g., witha sterilizing agent or a fresh PD solution. Vent 145 also helps reusablefill container 142 to gravity feed fresh PD solution to patient 16smoothly, while allowing and purifying air into fill container 142 todisplace the gravity fed fluid.

Sidewall 146 includes or is provided with a handle 158, which can be ahinged handle that is pulled up from sidewall 146 when desired so that auser, e.g., the patient or facility professional, can lift the entireunit 140, e.g., to a room or cubicle for use. In the illustratedembodiment, reusable fill container 142 is filled with PD solution andlaid on its side for mating with drain container 160. Other fill anddrain container configuration combinations are possible, however, theillustrated configuration combination advantageously distributes theliquid weight evenly over the entire footprint of CAPD unit 140.Assuming reusable fill container 142 to be reasonably full of fluid whentransported, fluid should not splash around too much. Handle 158 can belocated alternatively on top surface 144 of reusable fill container 142or on the top surface of drain container 160, so that CAPD unit 140hangs more vertically when carried.

Reusable drain container 160 in the illustrated embodiment includes atop wall 162, a bottom wall (not visible), sidewalls (not visible), afront wall 164 and a back wall (not visible). For transportation asillustrated in FIG. 6A, reusable drain container 160 is likewise laid onits side. Reusable drain container 160 can have a generally rectangular,six-sided shape as illustrated, or have rounded sides, oblong sides andmore or less than six sides or surfaces.

Top wall 162 includes a drain fluid inlet 168, which is fitted with acap 170 a. Cap 170 a can likewise be a threaded cap, e.g., luer cap,which threads onto a threaded end of drain fluid inlet 168. Cap 170 amaintains the threaded end of drain inlet 168 in a disinfected orsterilized condition. Top wall 162 and bottom wall (not visible) ofdrain container 160 each include (e.g., are molded with) or are providedwith a mounting peg 166 that removably accepts an end of a stretchablestrap 176, which the user (patient or facility professional) applies tohold CAPD unit 140 together, or removes to pull fill container 142 anddrain container 160 apart. Stretchable strap 176 can be made of astretchable nylon or bungee cord material. Strap 176 in the illustratedembodiment is thin so that it can fit easily beneath handle 158 ofreusable fill container 142. Strap 176 compresses to form fit toreusable drain container 160 when fill container 142 is removed so thatthe strap stays connected to and does not become lost from draincontainer 160 for storage.

Top wall 162, like top wall 144 of reusable fill container 142, can beprovided with a hydrophobic vent 167. Vent 167 helps reusable draincontainer 160 to be filled, e.g., with a disinfectant or sterilizingagent or with used effluent from the patient. Vent 167 helps reusabledrain container 160 to be gravity fed with effluent solution smoothly,allowing air to be displaced from container 160.

Front wall 164 of reusable drain container 160 in the illustratedembodiment includes (e.g., is molded with) or is provided with fourmounting pegs 174 that removably accept one corner each of a flexibleCAPD set pouch 180. Pouch 180 in the illustrated embodiment includes aninner chamber that is sealed at edges 184 to form outer tabs that definethe mounting holes for fitting removably over the mounting pegs 174 ofreusable drain container 160. In one embodiment, one of the edges 184 isconfigured to be opened for treatment and then resealed after pouch 180and its enclosed CAPD set 190 are cleaned and re-sterilized for anothertreatment. Resealable edge 184 can be of a tongue-and-groove type orinclude a zipper that closes two flaps together sealingly when zippedclosed to provide a robust, sealed and selectively openable closure forpouch 180. In an embodiment, all materials for pouch 180, including anyzipper or tongue-and-groove material are capable of withstanding atleast one of the sterilization procedures discussed herein.

Resealable pouch 180 holds a reusable CAPD set 190 discussed in moredetail below. Pouch 180 is provided with and carried by reusable draincontainer 160. When patient 16 proceeds with unit 140 to an areadesignated within facility 100 for treatment, the patient removesstretchable strap 176, so that fill container 142 can be lifted off ofdrain container 160. Pouch 180 is then pulled off of drain container 160and opened to allow CAPD set 190 to be removed for use. Connectingstretchable strap 176 and resealable pouch 180 to drain container 160enables each fill container 142 to be stored neatly and without appendedstructures, along with other fill containers 142, in a heatedenvironment. The PD solution should be heated to body temperature orabout 37° C. (98° F.) before delivery to the patient. It is contemplatedtherefore to provide one or more larger heated and insulated storagearea or tank within facility 100, e.g., in backroom 150, which heat(s)and maintain(s) the fill containers 142 to and at a desired temperature.Structuring fill containers 142 to be neat or devoid of appendedstructures also aids in the overall heating efficiency of facility 100.

Referring now to FIG. 6B, set 190 illustrates one embodiment for a CAPDset of the present disclosure. CAPD set 190 includes a patient line 192,a fill line 194 and a drain line 196. Patient line 192 is capped by aremovable cap 198 b, which when removed allows patient line 192 to beconnected to the patient's transfer set after the patient has removed acap 198 a from his/her transfer set. Fill line 194 is capped by aremovable cap 156 b, which when removed allows fill line 194 to beconnected to fill spout 152 of fill container 142 after the patient hasremoved cap 156 a from fill spout 152. Drain line 196 is capped by aremovable cap 170 b, which when removed allows drain line 196 to beconnected to drain inlet 168 of drain container 160 after the patienthas removed cap 170 a from drain inlet 168.

FIG. 6B also illustrates that drain line 196 includes a sample port 202.Sample port includes a pierceable septum 204, through which the patientcan insert a syringe or needle, e.g., after being disinfected withrubbing alcohol, to draw a patient effluent sample while the patient isdraining. The syringe can be held in the patient's possession or beprovided by and returned to treatment facility 100.

It is contemplated to modify CAPD set 190 so that it is more easilywashed, disinfected and re-sterilized between treatments. For example,it is contemplated to make one or more or all of patient line 192, fillline 194 and drain line 196 have a larger inner diameter, e.g., to be0.375 inch (9.5 millimeter) outer diameter, so that a mechanical brushor pipe cleaner type device can be inserted into the lines and movedback and forth to remove any fibrin or other materials left after anexchange. The inner walls of one or more or all of patient line 192,fill line 194 and drain line 196 can alternatively or additionally becoated with a physiologically safe, non-friction material. Or, lines192, 194 and 196 can be made of a low friction or slick material orversion of a material to reduce the amount of trapped fibrin or otherresidual materials. Alternatively or additionally, the wall of one ormore or all of patient line 192, fill line 194 and drain line 196 can bemade thicker so that CAPD set 190 can be subjected to higher pressuresduring cleaning with a pressurized water or detergent. Furtheralternatively or additionally, one or more or all of patient line 192,fill line 194 and drain line 196 can be made of or coated with anespecially chemically inert material, so that CAPD set 190 can besubjected to harsher detergents or other cleaning agents, such as ozone,or any of the sterilization agents or treatments listed above. Stillfurther alternatively or additionally, one or more or all of patientline 192, fill line 194 and drain line 196 can be made of a hightemperature resistance material, so that CAPD set 190 can be subjectedto prolonged high temperature or steam disinfection. Materials and tubessizes used for CAPD set 190 are selected so that they can be readilysanitized, e.g., disinfected and sterilized, and to remove any residualbody proteins or other materials left within the set.

FIG. 6B further illustrates that CAPD set 190 also includes an extrafresh transfer set cap 198 a. When patient 16 has completed a PDexchange using CAPD unit 140, the user places fresh transfer set cap 198a onto the patient's transfer set, which maintains the transfer set in aclean and protected state until it is time for the next exchange. Thepatient places the old transfer set cap 198 a into pouch 180 along withthe other used caps 198 b, 156 a/156 b and 170 a/170 b and the usedtubing for re-sterilization.

FIG. 6B also illustrates that as part of CAPD set 190, or used incombination with CAPD set 190, the patient can manipulate a flow controldevice 90 to select a desired flow path or a no-flow condition. Variousembodiments for flow control device 90 are disclosed in U.S. PatentPublication No. 2009/0143723, filed Nov. 29, 2007, entitled, “FlowControl Device For Peritoneal Dialysis”, the entire contents of whichare hereby incorporated by reference and relied upon. For ease ofillustration, flow control device 90 as illustrated includes a patientport 92, a fill port 94, a drain port 96 and a dial 98. In anembodiment, patient line 192 “Y's” or “T's” into fill line 194 and drainline 196. The “Y” or “T” tubing connector can be placed within flowcontrol device 90, so that patient line 192 extends through patient port92, fill line 194 extends through fill port 94, and drain line 196extends through drain port 96.

In the example of FIG. 6B, when dial 98 is turned so that the arrowsextending from dial 98 do not point towards any of the ports 92, 94 or96, flow control device 90 is in a no-flow condition, in which all lines192, 194 and 196 beneath the device 90 are occluded. When the patientrotates dial 98 counterclockwise (as indicated by the arrow in FIG. 6B),so that the arrows point towards patient port 92 and drain port 96, asthe patient is instructed to do initially, patient line 192 and drainline 196 open, allowing the patient to drain. When the patient rotatesdial 98 further counterclockwise, so that the arrows point towards fillport 94 and drain port 96, as the patient is instructed to do secondly,fill line 194 and drain line 196 open, allowing fill line 194 to primeand flush air to drain. When the patient rotates dial 98 still furthercounterclockwise, so that the arrows point towards patient port 92 andfill port 94, as the patient is instructed to do thirdly, patient line192 and fill line 194 open, allowing patient 16 to be filled with freshPD solution. When dial 98 is rotated between any of the drain, flush, orfill settings, control device 90 enters a no-flow condition, so thatpatient 16 can pause between the drain, flush and fill sequences.

Flow control device 90, like the syringe for sample port 102, can be theproperty of the patient or be provided alternatively by or returned totreatment facility 100. In the illustrated embodiment, it is assumedthat flow control device 90 does not actually contact any fluid, freshor effluent, and therefore does not need to be re-sterilized. In analternative embodiment, in which any one or more of patient line 192,fill line 194 or drain line 196 is connected fluidly to patient port 92,fill port 94 or drain port 96 (as opposed to running through the ports),so that alternative device 90 does contact fluid, flow control device 90is supplied via pouch 180 and placed within pouch 180 at the end oftreatment for re-sterilization. To be clear, however, pouch 180 can alsostore, supply and transport flow control device 90 even if the flowcontrol device does not contact fluid.

Referring now to FIG. 6C, treatment facility 100 putting CAPD unit 140into action is illustrated. For ease of illustration, only a singlepatient station 126 b is fully illustrated. But just like with theembodiments of FIGS. 4 and 5, it is contemplated for treatment facility100 of FIG. 6B to have multiple patient stations 126 a, 126 b, 126 c . .. 126 n, separated by respective walls or partitions 128 b, 128 c . . .128 n. Patient stations 126 a to 126 n can have any one, or more, or allof chair, sofa, bed, or the like 34, television 36, remote control 38,desk or table 40, and/or alternating current wall outlet 42 discussedabove in connection with FIG. 4. Stations 126 a to 126 c can likewise beclosed by a curtain, wall and/or door.

FIG. 6C illustrates that patient 16 has been given a CAPD unit 140 inthe form shown in FIGS. 6A and 6B and has transported the unit to adesignated patient station 126 b. Patient 16 has removed stretchablestrap 176, allowing reusable fill container 142 to be removed fromreusable drain container 160. Patient 16 has also reconnectedstretchable strap 176 so that it is now connected only to reusable draincontainer 160. In an embodiment weigh scale 56 is provided at patientstation 126 b. Patient 16 first places preheated, reusable fillcontainer 142 onto scale 56 and records (e.g., manually onto a piece ofpaper or entry into smart phone or tablet) or has recorded (e.g.,wireless signal from weigh scale 56 to one of facility computers 106 ato 106 f) the weight of fresh dialysate located within reusable fillcontainer 142. The weight of reusable fill container 142 is generallyknown and can be subtracted from the weight recorded by weigh scale 56or be assumed to be canceled out by the weight of reusable draincontainer 160 when the full drain container is weighed at the end of theexchange, wherein a difference between the drained effluent weight andthe fresh dialysate fill weight is recorded (manually or automaticallyas described above) as the patient's amount of ultrafiltration (“UF”)removed via the exchange.

Patient 16 next lifts preheated, reusable fill container 142 from weighscale 56 and places the fill container on a ledge, shelf, table orpedestal 134, which is set at, or has an adjustable height so as to beset at, an elevation that allows fresh, heated dialysate to flow at aproper gravity fed pressure that is safe for patient 16 (e.g., twopsig). Such height can be for example about two feet (0.60 meter).Patient 16 then places reusable drain container 160 onto the weigh scale56 next to his/her chair. It should be appreciated that weigh scale 56is not mandatory and that without it, patient 16 could instead firstplace reusable drain container 160 onto the ground next to his/her chairand then place reusable fill container 142 onto ledge, shelf, table orpedestal 134. It should be appreciated that patient stations 126 a to126 n and the corresponding facility 100 employing same are relativelysimple structurally. Facility 100 only needs front desk 104, a fillcontainer warmer and patient stations 126 a to 126 n. Patient stations126 a to 126 n in turn only need the chair, weigh scale 56, ledge,shelf, table or pedestal 134, and whatever other incidentals are neededfor patient comfort.

Patient 16 then connects CAPD set 190 to himself/herself, to reusablefill container 142, and to reusable drain container 160. To minimizepotential contamination, patient 16 removes the caps from a line andthen connects that line as soon as possible to its destination. Forexample, patient 16 can first remove cap 170 a from drain fluid inlet168 and cap 170 b from drain line 196, and then immediately connectdrain line 196 to drain fluid inlet 168. Next, patient 16 can remove cap156 a from filling spout 152 and cap 156 b from fill line 194, and thenimmediately connect fill line 194 to filling spout 152. Then, patient 16can remove transfer set cap 198 a from his/her transfer set and cap 198b from patient line 192, and then immediately connect patient line 192to the patient's transfer set (not illustrated). Fill line 194 and drainline 196 and possibly even patient line 192 are occluded during theabove connections via manual clamps, e.g., Halkey Roberts™ clamps, viaflow control device 90, or possibly using both manual clamps and flowcontrol device 90.

In the illustrated example, the six removed caps 156 a, 156 b, 170 a,170 b, 198 a and 198 b are placed onto ledge, shelf, table or pedestal134 for safekeeping. In FIG. 6C, pouch 180 is shown holding an extrasterilized transfer set cap 198 a, which patient 16 will remove frompouch at the end of the PD exchange to cap off the patient's transferset. Sterilized transfer set cap 198 a can be fitted with a smallenclosed antiseptic pocket prior to sterilization. The pocket is broken,spreading antiseptic over the tip of the patient's transfer set whenpatient 16 places cap 198 a onto the patient's transfer set at the endof an exchange. The antiseptic helps to maintain the patient's transferset in a sterilized state between exchanges. One suitable cap havingintegral disinfectant is set forth in U.S. Pat. No. 7,198,611, entitled,“Dialysis Connector And Cap Having An Integral Disinfectant”, assignedto the assignee of the present disclosure, the entire contents of whichare incorporated herein by reference and relied upon.

Patient 16 then either manipulates manual clamps, e.g., Halkey Roberts™clamps or flow control device 90 to perform the exchange. Again, manualclamps (not illustrated) and/or flow control device 90 can be theproperty of patient 16 or alternatively be loaned to the patient byfacility 100. If the components are the property of facility 100,patient 16 can return manual clamps (not illustrated) and/or flowcontrol device 90 to front desk 104 at the end of treatment, e.g., byplacing same into pouch 180 for refurbishing if needed and repacking.

Regardless of whether patient 16 uses manual clamps (not illustrated)and/or flow control device 90 with CAPD set 190, the drain, flush andfill routine is as described above. Patient 16 first removes clampsand/or sets flow control device 90 so that fill line 194 is closed,while patient line 192 and drain line 196 are opened to allow patient 16to drain effluent to reusable drain container 160. The drain fluidpushes air out of container 160, through hydrophobic filtered vent 167,so that container 160 does not push air elsewhere within from CAPD set190, and so that drain fluid flow is smooth.

In an embodiment, patient 16 sets the “Y” or “T” tubing connector ofCAPD set 190 so as to be roughly in a horizontal plane and/or monitorsthe amount of drain fluid that has entered reusable drain container 160(e.g., by watching how full the container is or by watching weigh scale56) and/or knows intuitively when drain is about to end, so that thepatient can end the drain phase of the exchange with effluent (but stillsterile) fluid remaining within patient line 192, preventing air fromentering same. To this end, it is typical for PD patients to drain themajority (e.g., eighty percent) of the effluent quickly and then hit anefficient flow wall, where the effluent flowrate drops significantly.During the low flow drain period, patient 16 can move around or stand upto reposition his or her indwelling catheter in an attempt to drain thelast percentage (e.g., twenty percent) of effluent. It is during thistime that patient 16 can be cognizant of patient line 192 so as to endthe drain phase with patient line 192 full. But even if patient line 192becomes partially or fully filled with air, (i) patient line 192 issmall so that there is only a small amount of air and (ii) the aireither comes from the patient himself/herself or from disinfected orsterilized reusable drain container 160, so that the air should notcarry contamination. At the end of drain, patient 16 removes drain line196 from container 160 and places drain cap 170 a back onto drain fluidinlet 168, so that a now full drain container 160 can be tipped andtransported.

At the end of the drain phase, or when patient 16 is not initially fullwith fluid, patient 16 sets manual clamps and/or sets flow controldevice 90 so that patient line 192 is closed, while fill line 194 anddrain line 196 are opened to allow patient 16 to prime and flush fillline 194, pushing air from line 194 to reusable fill or drain container142, 160. Patient 16 watches fill line 194 fill with fluid. When fillline 194 is completely full, patient 16 ends the fill line flush usingmanual clamps and/or flow control device 90. The fresh fluid level dropwithin reusable fill container 142 pulls and purifies air throughhydrophobic filtered vent 145, so that container 142 does not seekdisplacement air elsewhere from within from CAPD set 190, and so thatfluid flow during flush is smooth.

At the end of the prime and flushing phases, patient 16 sets manualclamps and/or sets flow control device 90 so that patient line 192 andfill line 194 are opened, while drain line 196 is closed to allowpatient 16 to gravity fill (at the desired head height pressure) withfresh fluid from container 142. The fresh fluid level drop withinreusable fill container 142 again pulls and purifies air throughhydrophobic filtered vent 145, so that container 142 does not seekdisplacement air elsewhere from within from CAPD set 190, and so thatfresh PD filling fluid flow to patient 16 is smooth.

Once the patient fill and thus the PD exchange has been completed,patient 16 can pack-up and proceed with his/her day or evening. It iscontemplated however that patient 16 could remain within facility 100for a predetermined dwell time and repeat the above procedure one ormore times, in which case patient 16 is given multiple CAPD units 140for use at patient station 126 b. Patient stations 126 a to 126 n can beprovided with warmers or insulated boxes (not illustrated) for storingone or more preheated reusable fill container 142. Or, patient 16 canreturn to front desk 104 each time, dropping off the old CAPD unit 140and receiving a new CAPD unit for the second, third, etc. exchange. Insuch case, warmers or insulated boxes are not needed at patient stations126 a to 126 n.

Before patient 16 returns to front desk 104, the patient removes sterilecap 198 a from pouch 180, disconnects patient line 192 from his/hertransfer set and places, e.g., threads, new sterile cap 198 a onto thetransfer set. Again, sterile cap 198 a can be loaded with disinfectantto kill any bugs that may appear due to the time that cap 198 a resideswithin pouch 180 or from the removal of patient line 192 from thetransfer set.

Patient 16 then collects CAPD set 190, the remaining five caps (draincap 170 a has been placed back onto drain fluid inlet 168) from ledge,shelf, table or pedestal 134 and possibly flow control device 90 and/ormanual clamps, and places same into pouch 180. The patient disconnectsstrap 176 from one of the mounting pegs 166 of drain container 160,places fill container 142 onto drain container 160, and reconnects strap176 to the peg 166 of the drain container. Patient 16 presses pouch 180onto mounting pegs 174 to reconstruct a used CAPD set 190 in the formillustrated in FIG. 6A. Patient 16 then uses handle 158 of fillcontainer 142 to return used CAPD set 190 to front desk 104. It iscontemplated to have patient 16 pay a deposit upon receiving fresh CAPDset 190, and for facility 100 to return the deposit to patient 16 onlyif pouch 180 is returned with all necessary reusable items, e.g., allcaps, used CAPD set 190, possibly flow control device 90, and/or manualclamps.

It should be appreciated that the above exchange produces no waste,eliminating disposable cost. The cost of the “reusables” is the cost oftransporting CAPD sets 190 and fluid containers to and from the place ofrefurbishment, the refurbishment itself, and the subsequent storage andheating at treatment facility 100.

Referring now to FIG. 6D, one operational flow system 270 for the CAPDunits 140 of FIGS. 6A to 6C is illustrated. System 270 is implementedfor a geographical area 272, which can for example be a denselypopulated city in a country currently having little or no dialysis orkidney failure treatment reimbursement. Example system 270 includes ninesatellite treatment facilities 100 a to 100 i. System 270 includes acentral refurbishing center 274, which can also serve as a tenthtreatment facility 100 j. The double arrows indicate two-way shippingbetween treatment facilities 100 a to 100 i and refurbishing center274/facility 100 j.

In one embodiment, used CAPD units 140 brought by patient 16 to frontdesk 104 are drained and then shipped as-is to refurbishing center274/facility 100 j for re-sterilization, disinfection and refilling.Refurbishing center 274/facility 100 j includes the equipment andchemicals needed (if necessary) to mechanically, chemically and/or heatsterilize reusable fill container 142, CAPD set 190, caps 156 a, 156 b,170 a, 170 b, 198 a and 198 b, and possibly reusable drain container160. Transfer set cap 198 a is fitted with a new disinfectant pouch inone embodiment. In an alternative embodiment, reusable drain container160 is disinfected, e.g., with hot water or steam, but is not subjectedto a sterilizing process.

In a further alternative embodiment, reusable drain container 160 is sodisinfected, but is disinfected at its satellite treatment facility 100a to 100 i. Here, shipping costs are reduced but each satellitetreatment facility 100 a to 100 i is then required to have adisinfecting, e.g., hot water bath or steam cleaning system. Also, ifpouch 180 with the used caps and CAPD sets 190 is to remain withreusable drain container 160, then each satellite treatment facility 100a to 100 i will need to have a way to sterilize CAPD set 190, caps 156a, 156 b, 170 a, 170 b, 198 a and 198 b, and to reload transfer set cap198 a with a disinfecting pocket. In such a case, it is contemplatedthat each patient 16 purchase a number of CAPD sets 190, which arecoded, e.g., barcoded, numbered, or otherwise specified for use onlywith that patient. This may provide an advantage however in that it maybe permissible to leave a biofilm on the insides of CAPD sets 190because the biofilm would be the patient's own film. Thus, used CAPDsets 190 and caps may only need mechanical cleaning and then hot wateror steam disinfection before being placed in a pouch, which is thensubjected to a sterilization process, e.g., UV radiation, to sterilizethe insides of the pouches and the outsides of CAPD sets 190. Whenpatient 16 enters treatment facility 100, the patient here receives oneof his/her own sets. Having two or more sets enables patient 16 to cometo facility 100 every day and receive a refurbished set, while thesecond or third set is being refurbished for the next day's exchange.

In still another alternative embodiment, if it is determined that it istoo difficult to clean CAPD sets 190, then the sets and likely the capscan be discarded after each use. Flow control device 90 and/or manualclamps can be reused. It is contemplated here to make the disposableclean CAPD sets 190 as cost effective as possible to make the PDexchanges as affordable as possible for the patient.

Referring now to FIGS. 7A and 7B, an alternative treatment facility 100using an alternative CAPD unit 240 is illustrated. Again for ease ofillustration, only a single patient station 136 b is fully illustrated.But just like with the embodiments of FIGS. 4 and 5, it is contemplatedfor treatment facility 100 of FIGS. 7A and 7B to have multiple patientstations 136 a, 136 b, 136 c . . . 136 n, separated by respective wallsor partitions 138 b, 138 c . . . 138 n. Patient stations 136 a to 136 ccan have any one, or more, or all of chair, sofa, bed, or the like 34,television 36, remote control 38, desk or table 40, and/or alternatingcurrent wall outlet 42 discussed above in connection with FIG. 4.Stations 136 a to 136 c can likewise be closed by a curtain, wall and/ordoor.

CAPD unit 240 includes reusable fill container 142 and reusable draincontainer 160 as they have been described above, including allassociated structure and alternatives. The primary difference betweenalternative CAPD unit 240 and CAPD unit 140 discussed above is that CAPDset 190 has been replaced with a simplified CAPD set 290. SimplifiedCAPD set 290 includes a single line or tube 292 capped at each end by apatient cap 294 and a drain/fill container cap 296. Line or tube 292 canbe made of any of the materials and have any of the diameters, lengthsand wall thicknesses discussed above for CAPD set 190. As illustrated inFIGS. 7A and 7B, line or tube 292 is long enough to reach both reusablefill container 142 and reusable drain container 160.

CAPD set 290, like CAPD set 190, also includes a pierceable septum 204,through which the patient can insert a syringe or needle, e.g., afterbeing disinfected with rubbing alcohol, to draw a patient effluentsample while the patient is draining Again, the syringe can be owned bythe patient or be provided by and returned to treatment facility 100.

FIG. 7A illustrates that patient 16 has been given a CAPD unit 240 andhas transported the unit to a designated patient station 136 b. Patient16 has removed stretchable strap 176, allowing reusable fill container142 to be removed from reusable drain container 160. Patient 16 has alsoreconnected stretchable strap 176 so that it is now connected only toreusable drain container 160. Patient 16 then places preheated, reusablefill container 142 onto scale 56 and records (e.g., manually on a pieceof paper or via entry into smart phone or tablet) or has recorded (e.g.,via a wireless signal from weigh scale 56 to one of facility computers106 a to 106) the weight of fluid within reusable fill container 142.

Patient 16 next lifts preheated, reusable fill container 142 from weighscale 56 and places the fill container on a ledge, shelf, table orpedestal 134, which is set at, or has an adjustable height so as to beset at, an elevation that allows fresh, heated dialysate to flow at agravity fed pressure that is safe for patient 16. Patient 16 then placesreusable drain container 160 onto the weigh scale 56 next to his/herchair. Again, weigh scale 56 is not mandatory and that without it,patient 16 can instead first place reusable drain container 160 onto theground next to his/her chair and then place reusable fill container 142onto ledge, shelf, table or pedestal 134.

FIG. 7A illustrates a drain procedure using CAPD unit 240. Here, withboth ends of line or tube 292 clamped via mechanical clamps (no need forflow control device 90 here), patient 16 removes cap 170 a from drainfluid inlet 168 and drain/fill container cap 296 from the distal end ofline or tube 292 and sets caps 170 a and 296 onto ledge, shelf, table orpedestal 134. The patient then connects the distal end of line or tube292 to drain fluid inlet 168 of drain container 160. Patient 16 thenremoves patient cap 198 a from the patient's transfer set and patientcap 294 from the proximal end of line or tube 292 and sets caps 198 aand 294 onto ledge, shelf, table or pedestal 134. The patient thenconnects the proximal end of line or tube 292 to the patient's transferset. The patient is now set to drain.

To drain as illustrated in FIG. 7A, patient 16 removes the manual, e.g.,Halkey Roberts™, clamps from line or tube 292, allowing effluent fluidto gravity flow from the patient's peritoneum to drain container 160.Hydrophobic cap 167 of drain container 160 allows air to vent whileeffluent fluid fills the container, enabling the effluent fluid to flowsmoothly from the patient's peritoneum to the drain container. Again,patient 16 will drain quickly at first and then hit a low flowratestage. At the low flowrate stage, patient 16 can stand up or maneuverhimself/herself to help drain the last portion of the patient's effluentfrom the patient's peritoneum. Patient 16 can draw a drain sample frompierceable septum 204 at any time during drain. When patient 16 is nearthe end of the drain phase (as determined by the patient using weighscale 56, level of drain fluid within container 160, or through acquiredknowledge), the patient clamps the distal end of line or tube 292 andremoves the distal end of the line from drain fluid inlet 168 of draincontainer 160, attempting to leave fluid in tube 292, so that the lineremains primed. Patient 16 then places drain cap 170 a back onto drainfluid inlet 168, so that a now full drain container 160 can be tippedand transported.

To fill with fresh fluid as illustrated in FIG. 7B, patient 16 removescap 156 a from fill container filling spout 152, and sets cap 156 a ontoledge, shelf, table or pedestal 134. Patient 16 moves the distal end ofline or tube 292 from fluid inlet 168 of drain container 160 to fillingspout 152 of reusable fill container 142 and connects the distal end tothe filling spout 152. Patient 16 then removes the manual clamp from thedistal end of line or tube 292 and opens manual on/off valve 154 ofreusable fill container 142. If for some reason line 292 is not primedor not fully primed, patient 16 can close a clamp at the proximal end ofline or tube 292, e.g., between the patient and pierceable septum 204.Fresh fluid from fill container should gravity feed line or tube 292,pushing the air up the line, into fill container 142 and out hydrophobicvent 145 of the container. If needed, a hydrophobic vent (notillustrated) can be incorporated into pierceable septum 204 of reusableline or tube 292, so that fresh fluid from fill container 142 gravityfeeding line or tube 292, can push air out of the hydrophobic vent (notillustrated) in a sterile manner. The hydrophobic vent may obviate theneed to leave line 292 primed after the drain phase. When priming iscompleted, the manual clamp at the proximal end of line or tube 292 canbe removed.

Fresh fluid from fill container 142 then fills the patient's peritoneum.When the fresh fluid fill is completed, the patient packs CAPD unit 240up in a similar manner discussed above for CAPD unit 140. In particular,before patient 16 returns to front desk 104, the patient removes a newsterile cap 198 a from pouch 180, disconnects line or tube 292 fromhis/her transfer set and places, e.g., threads, new sterile cap 198 aonto the transfer set. As before, sterile cap 198 a can be loaded withdisinfectant to kill any bugs that may appear due to the time that cap198 a resides within pouch or from the removal of patient line 292 fromthe transfer set. Patient 16 then collects the remaining three caps 198a, 294 and 296 (drain cap 170 a has been placed back onto drain fluidinlet 168) from ledge, shelf, table or pedestal 134 and possibly manualclamps, and places same into pouch 180. The patient disconnects strap176 from one of the mounting pegs 166 of drain container 160, placesfill container 142 onto drain container 160, and reconnects strap 176 tothe peg 166 of the drain container. Patient 16 then presses pouch 180onto mounting pegs 174 to reconstruct a used CAPD unit 240 in a formillustrated in FIG. 6A. Patient 16 then uses handle 158 of fillcontainer 142 to return the used CAPD unit 240 to front desk 104. It isagain contemplated to have patient 16 pay a deposit upon receiving thefresh CAPD set 240, and for facility 100 to return the deposit topatient 16 only if pouch 180 is returned with all necessary reusableitems, e.g., all caps, used CAPD unit 240, and possibly manual clamps.

It should be appreciated that the above exchange likewise produceslittle or no waste, greatly reducing or eliminating disposable cost. Thecost of the “reusables” is the cost of transporting CAPD sets 290 andthe containers to and from the place of refurbishment, the refurbishmentitself, and the subsequent storage and heating at treatment facility100.

The operational flow system 270 of FIG. 6D is equally applicable to CAPDsets 290 and units 240 of FIGS. 7A and 7B. In one embodiment, used CAPDsets 290 and units 240 brought by patient 16 to front desk 104 aredrained and then shipped as-is to refurbishing center 274/facility 100 jfor re-sterilization, disinfection and refilling. Refurbishing center274/facility 100 j includes the equipment and chemicals needed (ifnecessary) to mechanically, chemically and/or heat sterilize reusablefill container 142, CAPD set 190, caps 170 a, 198 a, 292 and 294, andpossibly reusable drain container 160. Transfer set cap 198 a is fittedwith a new disinfectant pouch in one embodiment. In an alternativeembodiment, reusable drain container 160 is disinfected, e.g., with hotwater or steam, but is not subjected to a sterilizing process.

Like before, reusable drain container 160 can be disinfected at itssatellite treatment facility 100 a to 100 i. Here, shipping costs arereduced but each satellite treatment facility 100 a to 100 i is thenrequired to have a disinfecting, e.g., hot water bath or steam cleaningsystem. Also, if pouch 180 with the used caps and CAPD sets 290 is toremain with reusable drain container 160, then each satellite treatmentfacility 100 a to 100 i will need to have a way to sterilize CAPD set290 and caps 170 a, 198 a, 294 and 296, and to reload transfer set cap198 a with a disinfecting pocket. In such a case, it is contemplatedthat each patient 16 purchase a number of CAPD sets 290, which arecoded, e.g., barcoded, numbered, or otherwise specified for use onlywith that patient. This may provide the advantages discussed above forCAPD set 190.

In still another alternative embodiment, if it is determined that it istoo difficult to clean CAPD sets 290, then the sets and likely the capscan be discarded after each use. It is contemplated here to make cleanCAPD sets 290 as cost effective as possible to make the PD exchanges asaffordable as possible for the patient. It should be appreciated howeverthat straight line CAPD sets 290 should be easier to clean, disinfectand sterilize than CAPD sets 190 discussed above.

Referring now to FIGS. 8A to 8G, an alternative treatment facility 100using an alternative filling system is illustrated. Again for ease ofillustration, only a single patient station 186 b is fully illustrated.But just like with the embodiments of FIGS. 4 and 5, it is contemplatedfor treatment facility 100 of FIGS. 8A to 8F to have multiple patientstations 186 a, 186 b, 186 c . . . 186 n, separated by respective wallsor partitions 188 b, 188 c . . . 188 n. Patient stations 186 a to 186 ncan have any one, or more, or all of chair, sofa, bed, or the like 34,television 36, remote control 38, desk or table 40, and/or alternatingcurrent wall outlet 42 discussed above in connection with FIG. 4.Stations 136 a to 136 n can likewise be closed by a curtain, wall and/ordoor.

The system of FIGS. 8A to 8G can use either CAPD set 190 or 290discussed above (illustrated here using set 190). CAPD set 190 or 290can again be provided in CAPD set pouch 180. It is contemplated toeliminate the caps used with CAPD set 190 or 290 and instead have pouch180 provide only a new patient transfer set cap 198 a, which can befitted with a disinfecting breakable pouch as has been described above.In a further alternative embodiment, pouch 180 is also eliminated andnew transfer set cap 198 a is placed instead onto the end of patienttube 192. If cap 198 a is provided with disinfectant, cap 198 a can bethreaded loosely onto patient tube 80 so that the disinfectant is notdisbursed.

Also, CAPD set 190 or 290 is in one embodiment not fully sterilized whengiven to patient 16. Instead, in between treatments, CAPD set 190 or 290is hot water disinfected to mechanically flush any residual fibrin orparticulates from the sets, so that the sets are free of any patientmatter. The hot water also partially sterilizes CAPD set 190 or 290. Ifdesired, a mild sterilizing agent can be added to the hot waterdisinfection, e.g., an organic solvent. If so, hot water is used at theend of the disinfecting process to flush the mild sterilizing agent fromCAPD set 190 or 290.

The final sterilization of CAPD set 190 or 290 takes places at patientstation 186 b using sterilizing unit 340 in various embodiments. InFIGS. 8A and 8F, sterilizing unit 340 includes a base 342 and a lid 360hingedly connected to base 342. Base 342 and lid 360 can be configuredto set on a table or ledge (FIG. 8F), such as ledge 134. In theembodiment illustrated in FIG. 8A, base 342 is alternatively providedwith its own set of legs 344 to prop base 342 and lid 360 up from theground. The inner surfaces of base 342 and lid 360 are in one embodimentmade of or coated with a ultraviolet (“UV”) light-reflective materialfor reasons discussed below. Patient 16 places CAPD set 190 or 290 andtransfer set cap 198 a into the clamshell between base 342 and lid 360and closes the clamshell. Sterilizing unit 340 then energizes the upperand lower arrays of UV lights or UV-LED's for a time sufficient to bringdisinfected CAPD set 190 or 290 and transfer set cap 198 a to a properlysterilized condition.

A power cord 346 runs from base 342 or lid 360 to power outlet 42. Poweroutlet 42 powers a plurality of UV lights 348, such as UV light-emittingdiodes (UV-LED's) provided in both base 342 and lid 360. The UV lights348 can alternatively be UV lamps. The UV lights 348 are connected inseries or parallel via one or more wire or printed circuit board trace350 (FIG. 8F). It is contemplated in one embodiment for the innersurfaces of base 342 and lid 360 to be ceramic or FR-4 printed circuitboards upon which one or more copper trace 350 is formed. The UV lights348 are surface mounted to the trace wires 350, e.g., either in seriesor parallel as desired. Alternatively, wires 350 form a mesh to whichthe UV lights 348 are hard-wired, soldered or are otherwise connectedelectrically. Still further alternatively, UV lights 348 are UV bulbsthat thread or plug into sockets provided by the inside surfaces of base342 and lid 360. The UV bulbs can likewise be wired together in a seriesor parallel relationship.

Power cord 346 plugs into a socket 352 located in base 342 in theillustrated embodiment. Power runs from socket 352 to a manual on/offswitch 354. It is contemplated to place switch in series electricalcombination with a second, mechanical switch (not illustrated) that isclosed when lid 360 is closed onto base 342. In this manner, lid 360must be closed before switch 354 is turned on for UV lights 348 toreceive power, preventing UV light energy from being emitted when unit340 is open, which could harm or disturb an outside entity. Switch 354can be located along any surface of sterilizing unit 340 for convenientreach and activation. In the illustrated embodiment, switch 354 is inelectrical communication with electronics 356. Electronics 356 caninclude one or more electrical component and perform one or morefunction, such as, conditioning and/or regulating incoming AC power intoa desired voltage and/or type (e.g., DC).

Electronics 356 can also include a timer that is preset to allow UVlights 348 to be powered for a prescribed amount of sterilization timeafter patient 16 places CAPD set 190 or 290 and transfer set cap 198 aonto base 342, closes lid 360, and presses switch 354 (e.g., amomentary, self-resetting switch). When the prescribed amount of timehas elapsed according to the timer, power to UV lights 348 is removedautomatically and a ready light and/or sound maker (not illustrated)is/are activated. Patient 16 can then remove CAPD set 190 or 290 fromsterilizing unit 340 for use. Transfer set cap 198 a can remain insidesterilizing unit 340 until the PD exchange is completed and patient 16needs a clean transfer set cap. The total disinfecting power from thecumulative light emitted by each of the UV lights 348 of base 342 andlid 360 is enough by an engineering factor to sterilize CAPD set 190 or290 within a reasonable period of time, e.g., two to ten minutes.

One advantage of performing the final sterilization of CAPD set 190 or290 at patient station 186 b is that the patient immediately thereafterconnects CAPD set 190 or 290 to the drain and/or fill containers, sothat CAPD set 190 or 290 does not have to be capped. Also, CAPD setpouch 180 may be eliminated altogether. Further still, new transfer setcap 198 a can be eliminated in an embodiment in which patient 16sterilized the existing cap 198 a using unit 340, e.g., while thepatient is draining and filling. Patient 16 at the end of the exchangehere replaces his/her own resterilized transfer set cap 198 a ontohis/her transfer set and takes used CAPD set 190 or 290 only up to frontdesk 104 for deposit redemption. Treatment facility 100 later that dayor that night collects all of the used and returned CAPD sets 190 and/or290 and possibly caps 198 a, places them in a hot water sterilizing bathor unit, the bath or unit circulates and flushes hot water through theinsides of CAPD sets 190 and/or 290, and filters the circulated water tocapture particulate and debris removed from the insides of CAPD sets 190and/or 290, removing such particulate and debris from the hot waterloop. The disinfected CAPD sets 190 and/or 290 are then dried and storedfor use later the same day or the next day.

It is expressly contemplated that sterilizing unit 340, and the usethereof to eliminate CAPD pouch 180, in combination with the hot waterdisinfection just described, can be used with any of the treatmentfacility embodiments described herein including those of FIGS. 6A to 6Dand FIGS. 7A and 7B. Regarding FIG. 6D, it is noted that the eliminationof CAPD set pouch 180 and the caps associated with CAPD sets 190 and290, as well as the in-facility 100 re-sterilization of the CAPD sets,reduces largely the amount of, and possible eliminates componentsneeding to be delivered to and from refurbishing center 274/treatmentfacility 100 j.

Reusable drain container 160 including all of its associated structureand alternatives can be used again with treatment facility 100 of FIGS.8A to 8G. Cap 156 a is again provided with drain container 160 and isremoved as illustrated in FIG. 8A for connection to CAPD set 190 or 290.It is contemplated to flush reusable drain container 160 with hot waterat treatment facility 100, as discussed above for CAPD sets 190 and 290,and to reuse caps 156 a, further eliminating the components that have tobe delivered to and from refurbishing center 274/treatment facility 100j. Because container 160 is a drain container, it does not need to becompletely re-sterilized. It is contemplated however to disinfect draincontainer 160 between uses, e.g., via hot water disinfection or a milddetergent, such as bleach.

FIGS. 8A and 8B illustrate that reusable fill container 142 discussedabove has been replaced with a permanent or semi-permanent fillingsystem 430. In general, filling system includes a fill container 432that is removably coupled to an energizing unit 460. Energizing unit 460remains in place, e.g., can be bolted to, ledge, shelf, table orpedestal 134 and is not transported back and forth by patient 16. FIG.8A illustrates that energizing unit 460 operates with a weigh scale 56in one embodiment, which can be separate from or made part of unit 460.Energizing unit 460 includes a pair of sterilizing panels 462 a/462 b, acontrol unit 480, a ready light 474, an electrically actuated fill valve464, and an electrically actuated dispense valve 466, among other items.

It is contemplated that fill container 432 remain at leastsemi-permanently coupled to energizing unit 460, e.g., over multipletreatments for multiple patients, over multiple days or even multipleweeks. Fill container 432 can be removed however for intermittentcleaning, repair or replacement. FIGS. 8A and 8C illustrate that fillcontainer 432 can include a hydrophobic vent 145, just as with reusablefill container 142. Semi-permanent fill container 432 in FIGS. 8A and 8Creceives fresh, but not necessarily sterile, water or peritonealdialysis solution via a fill line 434 and electrically actuated fillvalve 464 of energizing unit 460. Scale 56 of energizing unit 460operates with control unit 480 and electrically actuated fill valve 464to weigh the fresh fluid as it enters semi-permanent fill container 432.When the actual weight of the fresh fluid reaches the patient'sprescribed fill weight, control unit 480 causes fill valve 464 to close,leaving a prescribed amount of fresh fluid within fill container 432.When control unit 480 determines that the dialysate is (i) properlysterilized, (ii) at a proper chemical composition, and (iii) at a propertemperature, control unit 480 causes a ready light 474 to illuminate,enabling patient 16 to press a “GO” or “START” button on control unit480, which in turn causes outlet valve 464 to open and the filling ofthe patient to begin.

As illustrated below in FIG. 8E, scale 56 is in one embodiment combinedwith a heater 490 to heat fresh fluid within fill container 432. In analternative embodiment, the fresh fluid is heated to the propertemperature prior to flowing through fill line 434 to fill container432. Alternatively or additionally, sterilizing panels 462 a/462 b heat,or top off the needed heating, of fresh fluid residing within the fillcontainer. Semi-permanent fill container 432 in combination with the hotwater disinfection and the in-facility sterilization of CAPD sets 190and 290 described above with FIG. 8A eliminate the need for refurbishingcenter 274 altogether. Treatment facilities 100 a to 100 j canaccordingly operate self-sufficiently and independent of one another.

Referring now to FIGS. 8B to 8E, various embodiments of semi-permanentfilling system 430, fill container 432, and energizing unit 460 areillustrated in more detail. As discussed above, fill container 432 canbe removed from energizing unit 460 in certain instances as illustratedin FIG. 8C. Normally, however, fill container 432 sits within, and isacted upon by, energizing unit 460, as illustrated in FIG. 8B. Tofacilitate easy removal of fill container 432 from energizing unit 460,energizing unit 460 is generally three-sided, with sterilizing panels462 a/462 b providing two sides and a front panel 470 connected to thesterilizing panels 462 a/462 b providing the third side. Fill container432 is slid into and out from energizing unit 460 though the open backand/or top of unit 460. As illustrated, the top of energizing unit 460is alternatively or additionally left open so that fill container 432can be slid into and out from energizing unit 460 though the open top ofthe unit. The open top also allows for various structures to be mountedto the top of fill container 432. A notch 472 in front panel 470 allowsan outlet pigtail 436 of fill container 432 to extend outside of thefront panel 470 and unit 460.

Sterilizing panels 462 a/462 b and front panel 470 of energizing unit460 can be made of metal, e.g., stainless steel or aluminum. Fillcontainer 432 can be made of any of the plastic materials discussedabove, such as polypropylene (“PP”), high density polyethylene (“HDPE”),low density Polyethylene (“LDPE”), polycarbonate (“PC”), glycol-modifiedpolyethylene terephthalate (“PET-G”), polyvinyl chloride (“PVC”), andcombinations thereof. In one preferred embodiment, fill container 432 ismade of an ultraviolet (“UV”) light transmissive material.

In the illustrated embodiment, ready light 474, e.g., a green light, ismounted to front panel 470 and powered via wires 476 running to controlunit 480. Control unit 480 can be an off-the-shelf programmable logiccontroller (“PLC”), which accepts AC power from a source 42, acceptsanalogue and/or digital inputs from various external sensors, and sendsanalogue and/or digital outputs to external devices, such as,electrically actuated valves 464 and 466, sterilizing panels 462 a/462b, and one or more heating element if provided. Control unit 480 canalso power the sensors used with semi-permanent filling system 430, suchas a temperature sensor 494, conductivity sensor 494/496, glucose sensorand/or one or more load cell for weigh scale 56.

FIGS. 8B and 8D illustrate that control unit 480 can additionallyinclude a touch panel keypad 482 for a user to enter values into thememory of control unit 480 and/or to initiate a command, such as “GO”and “STOP”. Keypad 482 can for example be an electromechanical membraneswitch keypad or a touch screen keypad. One or more memory withincontrol unit 480 operates with one or more microprocessor of unit 480 toaccept user and sensor inputs, employ algorithms that interrogate suchinputs, and execute outputs to electrically actuate valves 464 and 466,sterilizing panels 462 a/462 b, one or more heating element 490, and thesensors 494 and 496. The one or more memory and processor also operateto display data as programmed on a display panel or device 484, such asa liquid crystal display (“LCD”) panel or a light emitting diode (“LED”)panel.

Ready light 474 or a similar marking or indicium can be displayedinstead on display panel 484. Display panel 484 alternatively oradditionally provides an indication of what percentage of a start-up(e.g., sterilization, and/or warming) procedure has transpired. Displaypanel 484 alternatively or additionally provides an indication of whatpercentage of a container 432 filling or emptying procedure hastranspired. Display panel 484 alternatively or additionally walkspatient 16 through the PD treatment setup steps and asks patient 16 topress “GO” when a step is completed, after which control unit 480displays the next treatment step to be performed or begins treatment ifsetup has been completed.

Display panel 484 in an embodiment displays the numerals 0 to 9 thatpatient 16 presses to enter parameter valves using keypad 482. Forexample, one treatment setup step may be for the patient to enter thepatient's prescribed fill volume. Display panel 484 prompts patient 16to do so. Patient 16 uses keypad 482 to enter the volume (e.g., inliters). Display panel 484 displays the inputted volume back to patient16. Patient 16 then presses the confirm or “GO” button. Control unit 480converts the patient's volume or liter input to grams, so that theoutput of weigh scale 56 can be compared against the inputted weight. Ifpatient 16 enters a fill volume that is greater than the capacity ofcontainer 432, display panel 484 can display an error message and promptpatient 16 to enter a different amount.

Alternatively, patient 16 uses keypad 482 to enter a patientidentification (“ID”) code. Control unit 480 is connected to a networklinking all facility 100 computers 106 a to 106 f to 100 n to all of thecontrol units 480 located within facility 100. A storage or memory incommunication with the network stores the patient's ID code along withtreatment prescription information, such as fill volume and solutiontype. In one embodiment, once patient 16 enters his/her code, thestorage or memory for the network recalls the patient's profile andsends a confirmation prompt to display panel 484, such as, “pleaseconfirm that you are Jane Doe”. The patient confirms their identity,e.g., via pressing the “GO” button, or indicates that there is anidentity mismatch, e.g., via pressing the “STOP” button. If an identitymismatch occurs, the network can display a message on display panel 484requesting the patient to reenter their ID code and then repeat theconfirmation process. If the identity mismatch continues, a facilityprofessional 18 can be summoned. Once patient 16 confirms that thenetwork has properly identified the patient, the network knowing thepatient's profile automatically instructs control unit 480 to cause theproper fill volume to be filled into container 432 and prompts patient16 to cause the proper type of dialysate to be made and/or delivered.Using the patient ID prevents patient 16 from entering a fill volumedifferent than the patient's prescribed fill volume. The patient's IDand profile can be stored on the one or more memory device of controlunit 480 alternatively or additionally to that of the facility network.

Further alternatively, patient 16 is provided with an identification(“ID”) tag in the form of a card, wristband, keychain tag, necklace tagor the like. The tag includes a barcode, radio frequency tag (“RFIDtag”) or other readable structure, energy type or indicia. Energizingunit 460 is in turn provided with a corresponding reader, e.g., barcode,RFID or other reader (not illustrated) that is in data flowcommunication with control unit 480. Patient 16 in one embodiment scanshis/her tag across the reader. The scanned information is delivered fromcontrol unit 480 to the network where the patient's profile is pulled.The network knowing the patient's profile automatically again instructscontrol unit 480 to cause the proper fill volume to be filled incontainer 432 and causes or prompts patient 16 to cause the proper typeof dialysate to be made and/or delivered. Using the patient ID taglikewise prevents patient 16 from entering a fill volume different thanthe patient's prescribed fill volume and also prevents the patient fromhaving to remember an ID code. The patient's ID profile can again bestored on the one or more memory device of control unit 480alternatively or additionally to that of the facility network.

Both the ID code and ID tag embodiments can also require that a patientpassword be entered to prevent someone who improperly uses someoneelse's ID code or ID tag from receiving a treatment.

Once the proper fill volume is confirmed via any of the techniquesdiscussed above, control unit 480 proceeds to cause energizing unit 460to open fill valve 464, while keeping dispense valve 466 closed.Referring to FIGS. 8B and 8D, in the illustrated embodiment fill valve464 and dispense valve 466 are spring-closed, energized-open,electrically actuated solenoid pinch valves. Valves 464 and 466 areaccordingly fail safe because they will close automatically when poweris removed or lost, placing semi-permanent filling system 430 into ano-flow state. Valves 464 and 466 are connected to control unit 480 andthus energizing unit 460 by electrical cabling 464 a and 466 a,respectively. Electrical cabling 464 a and 466 a enables control unit480 to selectively power valves 464 and 466. The electrical cabling alsoprovides a flexible connection of valves 464 and 466 to energizing unit460, so that the valves can be lifted away from fill container 432 forits removal (FIG. 8D), while still remaining attached to energizing unit460.

Valves 464 and 466 include a press-bar 464 b and 466 b, respectively,which are each mechanically attached to the body of the respectivevalve. Pigtail tubes 436 and 438 of fill container 432 become compressedbetween the valve plungers and the press-bars 464 b and 466 b when poweris removed from the valves. Valves 464 and 466 each also include alocking pin 464 c and 466 c, respectively, which connect hingedly in oneembodiment to the body of the valves and rotatably snap-fit into placeonto their respective press-bars 464 b and 466 b. When snap-fitted intoplace, locking pins 464 c and 466 c prevent valves 464 and 466 fromcoming free from pigtails 436, 438 even when the valves are energized,pulling valve plungers free from press-bars 464 b and 466 b. When afacility professional 18 wishes to remove valves 464 and 466 from theirrespective tubes, e.g., to remove container 432 from energizing unit460, facility professional 18 unlocks locking pins 464 c and 466 c,rotates the pins away from press-bars 464 b and 466 b, respectively,energizes valves 464 and 466 so that the valve plungers no longer pinchtubes 436, 438, and pulls valves 464 and 466 away from the tubes. Withvalves 464 and 466 removed, container 432 is free to be pulled away fromenergizing unit 460.

To manually energize valves 464 and 466 in one embodiment, e.g., forvalve placement and removal, valve testing, or other reason, it iscontemplated to allow facility professional 18 to enter a service modevia control unit 480. Each energizing unit 460 can have a service modecode that is entered via keypad 482. When the proper code is entered,energizing unit 460 enters a service mode and displays a number ofservice mode options to facility professional 18 on display panel 484.One such option could be to toggle or energize valves 464 and 466. Atouchable button could be displayed on display device 484 for each valve464 and 466. Or an instruction, such as “Touch 1 to open the fillvalve”, “Touch 2 to open the dispense valve”, can be displayed ondisplay device 484 so that keypad 482 can be used to toggle the valves.In any case, it is contemplated that when facility professional 18selects a display or keypad button to open one of valves 464 or 466,that control unit 480 control unit maintain the valve in an open statefor a predefined period of time without further button pressing fromfacility professional 18, so that the facility professional can havefree hands to either apply valves 464 and 466 to tubes 436 and 438 orremove the valves from respective tubes.

When control unit 480 opens fill valve 464 and inlet pigtail 438, whilekeeping dispense valve 466 and outlet pigtail 436 closed, fill container432 begins to fill with liquid, e.g., purified or sterilized water orpurified or sterilized dialysate as discussed in more detail below. Asliquid fills within fill container 432, hydrophobic vent 145 enablesdisplaced air to escape. Also, weigh scale 56 measures the weight of theentering fluid. Weigh scale or load cell 56 is illustrated in FIGS. 8A,8B, 8D and 8E. The top view of energizing unit 460 in FIG. 8E shows thatweigh scale 56 can include a single sensor, e.g., a load cell or straingauge. Alternatively, weigh scale 56 can include multiple sensors whoseoutputs are combined to produce a single accurate weight reading.

As alluded to above, the reading from weigh scale 56 is received bycontrol unit 480 and compared against the commanded fill volume orweight. Once the actual volume or weight of liquid inside fill container432 reaches the commanded volume or weight, control unit 480 closes fillvalve 464 and inlet Pigtail 438. During the fill, it is contemplated toshow patient 16 at display device 484 how much of the fill hastranspired in relation to how much more filling needs to take place. Thedynamic fill display can be shown as an ever-increasing instantaneouspercentage number, as a character or shape that becomes increasinglycolored with a fill color, and/or with an ever-increasing actualinstantaneous volume number or weight number of the current fill. Thefill display allows the patient to ascertain how much more filling timeis needed. It is contemplated that patient 16 perform any neededdraining while fill container 432 is filling. Patient 16 drains intoreusable drain container 160 according to any of methods andalternatives and using any of the structure discussed above.

Once filling is completed, the next step depends upon the type of liquidand the state of the liquid that has been delivered to fill container432. The present disclosure contemplates at least eight scenarios: (i)fill container 432 has been filled with unheated, purified dialysate,(ii) fill container 432 has been filled with heated, purified dialysate,(iii) fill container 432 has been filled with unheated, sterilizeddialysate; (iv) fill container 432 has been filled with heated,sterilized dialysate, (v) fill container 432 has been filled withunheated, purified water, (vi) fill container 432 has been filled withheated, purified water, (vii) fill container 432 has been filled withunheated, sterilized water, and (viii) fill container 432 has beenfilled with heated, sterilized water.

Only under scenario (iv), where fill container 432 has been filled withheated, sterilized dialysate, can control unit 480 proceed to opendispense valve 466 and outlet pigtail 436, while keeping fill valve 464and inlet pigtail 438 closed, to empty fill container 432 and fillpatient 16. Each of the other scenarios (i) to (iii) and (v) to (viii)requires additional input from energizing unit 460. In particular,scenario (i) requires heat and sterilization, scenario (ii) requiressterilization, scenario (iii) requires heat, scenario (v) requires heat,sterilization, and dialysate additives, scenario (vi) requiressterilization and dialysate additives, scenario (vii) requires heat anddialysate additives, and scenario (viii) requires dialysate additives.

Regarding scenarios (i), (iii), (v) and (vii) that require heating ofthe liquid, it is contemplated to heat the liquid (a) prior to beingdelivered through fill line 434 to fill container 432, (b) while beingdelivered through fill line 434 to fill container 432, (c) whileresiding within fill container 432, and (d) any combination thereof. Theliquid (water or dialysate) should be heated to about 37° C. (98° F.) orbody temperature before being delivered to patient 16. Thus if facility100 is located in a hot climate, the water or dialysate may be able tobe stored in a non air-conditioned room and then heated the extradegrees to the desired temperature at fill container 432. Alternativelyor additionally, the water or dialysate could be heated in a largerstorage tank in a back room, e.g., in storeroom 150 discussed below inconnection with FIG. 10, prior to delivery to fill container 432.Further alternatively or additionally, heating coils, e.g., heated toabout 37° C. (98° F.), could be wrapped around fill line 434 to heat thefluid residing within the fill line. In either of the final twoscenarios, heating at fill container 432 may not be required asspecified in scenarios (ii), (iv), (vi) and (viii). However, forscenarios (i), (iii), (v) and (vii), heating at fill container 432 couldbe provided additionally, so that if needed, heating a couple extradegrees to reach 37° C. (98° F.) can be performed.

In any of the heating scenarios just described that involve heating atfill container 432, it is contemplated to provide one or more resistiveheating coil or element 490 as illustrated in FIG. 8E. In theillustrated embodiment, heating coil or element 490 resides within aheating plate 492 upon which fill container 432 sits. Heating plate 492can in turn sit on top of the one or more sensor (e.g., load cell orstrain gauge) of weigh scale 56. The constant weight of the heatingplate 492, heating coil or element 490 and empty fill container 432 iszeroed out before weigh scale 56 reads the weight of fluid within fillcontainer 432 or is subtracted from the detected weight of the combinedempty fill container 432, heating plate 492, heating coil or element 490and fill fluid.

Control unit 480 in one embodiment controls a power duty cycle(percentage on versus off or percentage of full power) to heating coilor element 490, so as to heat the water or dialysate as quickly andsafely as possible to about 37° C. (98° F.). In one embodiment, twoheating coils or elements 490 of the same overall resistance areprovided, which combined extend to as to canvas the entire area ofheating plate 492. A voltage detection circuit (not illustrated) isprovided with control unit 480. The voltage detection circuit detectsthe incoming line voltage and relays same to the processing and memoryof control unit 480. Control unit 480 also includes switching circuitry,such that if a higher line voltage is detected, e.g., 190 to 250 VAC,control unit 480 commands the switching circuitry to cause the dual,equal resistance heating coils or elements 490 to be powered in series.If a lower line voltage is detected, e.g., 80 to 140 VAC, control unit480 commands the switching circuitry to cause the dual, equal resistanceheating coils or elements 490 to be powered in parallel. The result isthat coils or elements 490 output roughly the same amount of heatingpower or wattage regardless of the incoming line voltage. Filling system430 can accordingly be used in different countries having differentincoming line voltages and nevertheless use the same heating algorithm.

The duty cycle control algorithm that control unit 480 uses to heatwater or dialysate uses temperature feedback from one or moretemperature sensor 494 in one embodiment. Temperature sensor 494 isillustrated in FIGS. 8B, 8D and 8E and can be a thermistor orthermocouple in various embodiments. As illustrated in FIGS. 8B and 8C,to help maintain a sterile environment within fill container 432, apermanent metal, e.g., stainless steel, probe 442 extends down into thefill container. Probe 442 contacts the water or dialysate when fillcontainer 432 is filling. Heat from the water or dialysate conducts upmetal probe 442, which extends partly out of the top surface 450 of fillcontainer 432. The portion of metal probe 442 extending out the topsurface 450 of fill container 432 extends partway into a coupler 444,which is in one embodiment molded with fill container 432. Coupler 444leaves room for temperature sensor 494 to be inserted into and heldpress-fittingly in place by the coupler as illustrated in FIG. 8B.Temperature sensor 494 dead ends against metal probe 442, so that heatfrom the water or dialysate can further conduct from probe 442 totemperature sensor 494, which generates a corresponding signal that issent back to control unit 480.

FIGS. 8C and 8D illustrate that temperature sensor 494 can be pulledfrom coupler 444 of fill container 432 to remove fill container 432 fromenergizing unit 460, e.g., to replace temperature sensor 494, or for anyother desired reason. Probe 442 can extend any desired distance intofill container 432 including down towards the bottom of the container.

Control unit 480 in one embodiment uses the signal from one or moretemperature sensor 494 as feedback in its control algorithm. Generallyspeaking, the further away actual liquid temperature as sensed by one ormore temperature sensor 494 is below the commanded temperature, e.g.,about 37° C. (98° F.), the higher the heating duty cycle applied tocoils or elements 490. It is contemplated for control unit 480 to storeand use proportional, integral and derivative (“PID”) control to heatthe water or liquid to the commanded temperature quickly and with littletemperature overshoot.

In the above scenarios (iii), (iv), (vii) and (viii) not requiringsterilization at fill container 432, sterilization is performed inbackroom 150 or at an off sight, e.g., central, location after which thesterilized fluid is shipped to facility 100. Sterilization performedlocally in backroom 150 is done, e.g., in a large vessel, via anytechnique listed herein, such as, through the use of hydrogen peroxidevapor, gamma irradiation, peracetic acid, ethylene oxide, ethanol,formalin, glutaraldehyde, low energy electron beam and/or any othersterilization method known in the art. Performing certain of thesemethods in backroom 150, away from patient 16, is preferred for safetyreasons.

Regarding scenarios (i), (ii), (v) and (vi) above requiring finalsterilization at fill container 432, FIGS. 8D and 8E illustrate thatsterilizing panels 462 a and 462 b are provided with energizing unit 460in one embodiment. Sterilizing panels 462 a and 462 b in the illustratedembodiment each supply a plurality of plurality of ultraviolet (“UV”)lights 498, such as UV light-emitting diodes (UV-LED's) or UV lamps. TheUV lights 498 are connected in series in one embodiment via one or morewire or printed circuit board trace 500. It is contemplated in oneembodiment for the inner surfaces of sterilizing panels 462 a and 462 bto be ceramic or FR-4 printed circuit boards upon which one or morecopper trace 500 is formed. The UV lights 498 are surface mounted to thetrace wires 500, e.g., either in series or parallel as desired.Alternatively, wires 500 form a mesh to which the UV lights 498 arehard-wired, soldered or are otherwise connected electrically. Stillfurther alternatively, UV lights 498 are UV bulbs that thread or pluginto sockets provided by or at the inside surfaces of sterilizing panels462 a and 462 b. The UV bulbs can likewise be wired together in a seriesor parallel relationship.

To aid in the sterilization of liquid within fill container 432, and toincrease energy efficiency, it is contemplated to form or coat topsurface 450, front surface 452, rear surface 454, and if needed thebottom surface of fill container 432 (see FIG. 8C) with a UV lightreflective material. Side surfaces 456 and 458 of fill container 432located directly adjacent to sterilizing panels 462 a and 462 b,respectively, are made of a UV light transmissive material. Asillustrated in FIG. 8C, it is also contemplated to make side surfaces456 and 458 of fill container 432 relatively broad and front surface 452and rear surfaces 454 relatively narrow, so that the depth of UV lightpenetration needed is lessened. For example, the horizontal length ofside surfaces 456 and 458 can be three or four times as long as thehorizontal length X of front and back surfaces 452 and 454.

The total disinfecting power from the cumulative light emitted by eachof the UV lights 498 of sterilizing panels 462 a and 462 b is enough byan engineering factor to sterilize the water or dialysate within areasonable period of time, e.g., five to ten minutes, or the timeduration needed to also heat the water or dialysate. It is believed thatUV disinfection is more effective when treating highly purified water,e.g., reverse osmosis or distilled water. Suspended particles can becomea UV sterilization problem because microorganisms buried withinparticles are shielded from the UV light. It is contemplated however topurify the water or dialysate prior to reaching fill container 432 viaany of the purification systems discussed herein. The purificationsystem can for example be located in backroom 150 to pre-filter andremove larger organisms before they reach fill container 432. The pureor ultrapure water or dialysate received in fill container 432 alsoclarifies the liquid to improve light transmittance and therefore UVdose throughout the container 432. Also, because the water or dialysateis trapped within container 432, and sterilized on a batch basis, the UVlight should have the time and opportunity to impinge any remainingparticles or microorganisms trapped within the liquid.

It is further contemplated to rely upon any heat delivered by UV lights498 to the water or dialysate in the overall heating of same. Thus it iscontemplated that a combination of ambient pre-heating, heating fromcoils or elements 490, and heating from UV lights 498 is sufficient toheat the water or dialysate to body temperature within a reasonableperiod of time, e.g., the time needed for the patient to drain and/orthe time needed for proper UV sterilization.

In the illustrated embodiment, there is no feedback sensor forsterilization. Adequate sterilization time is determined empiricallybase upon certain factors, such as, facility water supply quality, typeand amount of pre-filtering, sterilization volume within fill container432, and power output from sterilizing panels 462 a and 462 b. Thus thesterilization time can be seen as a benchmark. If ambient pre-heating,heating from coils or elements 490, and heating from UV lights 498 canbe effectively accomplished at fill container 432 within or around thetime needed for UV sterilization, then such heating may be preferred sothat separate large batch heating in backroom 150 is not needed and isinstead done on an on-demand basis at fill container 432. In such acase, backroom 150 may only need a water or dialysate purification unit,which purifies the liquid needed for each of the patient stations 186 ato 186 n. It is further contemplated to insulate each of the lines,e.g., fill line 434, leading to patient stations 186 a to 186 n tolessen heat loss during fluid travel.

It is contemplated to automate the heating and/or sterilizationassociated with energizing unit 460 so that patient 16 does not have tocommence those processes. To do so, control unit 480 in one embodimentwaits until a certain amount of fill liquid is introduced into fillcontainer 432 before firing heating elements or coils 490 and/orsterilization panels 462 a and 462 b. Once weigh scale 56 signals that apredefined amount of fill liquid is present (e.g., ⅕th full), controlunit 480 actuates heating elements or coils 490 and/or sterilizationpanels 462 a and 462 b. Heating elements or coils 490 can be actuatedbefore or after sterilization panels 462 a and 462 b. In an embodiment,control unit 480 requires both the predefined weight signal from scale56 and knowledge that valves 464 and 466 are in their fill state toactuate heating elements or coils 490 and/or sterilization panels 462 aand 462 b. The combination requirement prevents a false weight signal(e.g., item placed on fill container 432) from inadvertently activatingthe heaters and sterilizing panels when no fill is taking place.

Referring now to FIG. 8G, for any of the scenarios (v) to (viii) listedabove in which additives need to be mixed with purified water to producedialysate, it is contemplated to provide a sterilized packet 510 thatcontains powdered additives, which when mixed with the proper volume ofpurified or disinfected water form a correctly formulated prescribeddialysate. In an embodiment, patient 16 receives a prescribed sterilizedpacket 510 from facility professional 18 upon approaching front desk 104(FIG. 3). In an alternative embodiment, patient 16 pre-purchasesmultiple packets 510 and brings one or more packet 510 to facility 100each visit for use. Patient 16 can be provided with packets 510 ofvarying formulations that allow the patient to tailor the treatmentbased upon what is needed that day. For example, if patient 16 feelsheavy and overhydrated on a particular day, the patient could choose apacket 510 prescribed by a doctor for removing extra ultrafiltration(“UF”). Or if patient 16 has had UF removed in a previous exchange butwants more clearance, the patient could choose a prescribed low UFremoved packet.

Packets 510 in the embodiment illustrated in FIG. 8G provide certaininformation such as dialysate type, e.g., by tradename, such as DIANEAL™or EXTRANEAL™ PD solution. The illustrated packet 510 also specifiesdialysate additive constituents, such as, osmotic agents (e.g., glucoselevel, dextrose level and/or other high and low molecular weight agentlevels), buffers (e.g., lactate level, acetate level, and/or bicarbonatelevel), and/or electrolytes (e.g., sodium level, calcium level,magnesium level, and/or potassium level). The illustrated packet 510further specifies the purified water volume that needs to be mixed withthe additives, e.g., two liters. It is expressly contemplated to provideone or more electrolyte, e.g., sodium, in a concentration that is higherthan what is normal for a peritoneal dialysis solution. The reason forthis is to raise the conductivity of the dialysate mixed from purifiedor sterilized water and additives to a level that can be sensed bysensors 494 and 496 as discussed below. Any one or more electrolytecould be raised as needed for such purpose but to a level that is stillphysiologically safe for patient 16.

Packets 510 can be sterilized then sealed, e.g., vacuum sealed, orsealed, e.g., vacuum sealed, then sterilized. Sterilization can beperformed via any of the methods discussed herein. Packets 510 can beconfigured to be torn open at a break point, cut open near a seam or beprovided with a tear-away tab. In an embodiment, packets 510 are alsoprovided with readable indicia 512, such as a barcode, that is read by asuitable reader (not illustrated) located at filling system 430.Readable indicia 512 provides information to control unit 480, such assolution type, water mix volume needed, and/or expiration date. It istherefore expressly contemplated to let packet 510 tell control unit 480how much purified water to allow into fill container 432, under theassumption that the patient 16 has been provided with the correct typeof packet 510. The patient identity checks discussed above mayaccordingly not be needed or may be performed in addition to, or as acheck upon, the information provided by packet 510. Control unit 480 canalso maintain an internal clock of date and time, so that if controlunit 480 detects that packet 510 has expired, control unit 480 sounds analarm, prevents filling, and/or notifies a facility professional 18.

FIGS. 8B and 8C illustrate that fill container 432 is provided in oneembodiment with a removable, e.g., threaded cap 440. Control unit 480via display device 484 in an embodiment prompts patient 16 to remove cap440, open packet 510, and pour the contents of packet 510 into anunfilled fill container 432. Control unit 480 via display device 484 canthen display a selectable “PACKET EMPTIED” button or display a messagesuch as “Touch GO when packet is completely empty”. Once patient 16 hasconfirmed that packet 510 has been emptied into container 432, subjectto any identity verification requirement, control unit 480 commands fillvalve 464 to open to being filling. The turbulence of purified waterentering fill container 432 thoroughly dissolves and mixes thegranulated additives of packet 510.

FIGS. 8B to 8E illustrate that energizing unit 460 in an embodiment alsoprovides a conductivity sensor 496. Conductivity sensor 496 operatesalongside temperature sensor 494 to form a conductivity sensor pair.Control unit 480 uses the signal from temperature sensor 494 tocompensate for temperature and the signal from conductivity sensor pair494 and 496 to produce an accurate conductivity reading. As illustratedin FIGS. 8B and 8C, to help maintain a sterile environment within fillcontainer 432, a permanent metal, e.g., stainless steel, probe 446extends down into the fill container as far as is needed. Probe 446contacts the water or dialysate when fill container 432 is filling.Electricity flows through conductivity sensor 496, probe 446, thedialysate, probe 442, and sensor 494 to and from a sensing circuitlocated within control unit 480. The higher the conductivity of thedialysate, the higher the current sensed at the sensing circuit.

The portion of metal probe 446 extending out the top surface 450 of fillcontainer 432 extends partway into a coupler 448, which is in oneembodiment molded with fill container 432. Coupler 448 leaves room forconductivity sensor 496 to be press-fittingly inserted into and held inplace by the coupler as illustrated in FIG. 8B. Conductivity sensor 496dead ends against metal probe 446, so that electricity from thedialysate can further conduct from probe 446 to temperature sensor 496,back to control unit 480. FIGS. 8C and 8D also illustrate thatconductivity sensor 496 can be pulled from coupler 448 of fill container432 to remove fill container 432 from energizing unit 460, to replaceconductivity sensor 496, or for any other desired reason. Probe 448 canextend any desired distance into fill container 432, including downtowards the bottom of the container.

Control unit 480 in one embodiment uses the signal from conductivitysensor pair 494 and 496 as confirmation that the dialysate has beenmixed with the proper volume of purified water. The primary mixingcontrol is to fill container 432 to the prescribed amount. If that isdone, the dialysate should be mixed properly. The conductivity readingcan be used as a confirmation that the dialysate is properly mixed. Whenthe powdered additives of packet 510 are dissolved in only a smallamount of purified water, the conductivity level should be higher thanwhen the additives are dissolved in the prescribed volume. Control unit480 monitors the dropping conductivity level as filling occurs andeither confirms that the actual final dialysate conductivity is withinan acceptable prescribed range or alarms and/or notifies facilityprofessional 18 when the final conductivity level is outside of (higheror lower) the accepted conductivity range.

Based on the foregoing description of FIGS. 8A to 8G, in one scenario inwhich all three of heating, sterilization and dialysate mixing is takingplace at permanent or semi-permanent filling system 430, the sequence ofevents in one example proceeds as follows (steps do not have to followin the stated order):

-   -   (i) patient 16 arrives at patient station 186 b with a dialysate        additive packet 510 brought from home or obtained at front desk        104, along with a reusable drain container 160, CAPD set 190 or        290 and a new patient transfer set cap 198 a;    -   (ii) patient 16 places CAPD set 190 or 290 and new patient        transfer set cap 198 a into sterilizing unit 340 and commences        final sterilization of the set and cap;    -   (iii) patient 16 opens packet 510, empties its contents into        empty fill container 432, and closes the container;    -   (iv) patient 16 enters a volume directly, enters a patient ID,        scans an ID tag or scans packet 510 to load a fill volume into        control unit 480, and upon patient and volume verification,        filling system 430 begins a filling procedure that includes        filling container 432 with water and activating fluid heating        and final fluid disinfection automatically at some point during        filling;    -   (v) during filling, patient 16 removes existing patient transfer        set cap 198 a, connects CAPD set 190 or 290 to the patient's        transfer set, reusable drain container 160, and fill container        pigtail 436 (CAPD set 190) or just to the patient's transfer set        and reusable drain container 160 (CAPD set 290), and commences a        patient drain;    -   (vi) when the drain is complete, and when ready light 474 is lit        indicating that dialysate volume, sterility, temperature and        composition are satisfactory for patient delivery, patient 16        either (a) commences a flush sequence from fill container 432 to        reusable drain container 160, followed by a dispense to patient        sequence from fill container 432 to the patient 16 using GO and        STOP buttons, flow control device 90 and CAPD set 190, or (b)        removes the distal end of CAPD set 290 from reusable drain        container 160, connects same to fill container pigtail 436, and        commences a dispense to patient sequence from fill container 432        to the patient 16 using GO and button and perhaps a pinch clamp        if CAPD set 290 requires priming;    -   (vii) when the dispense to patient or patient fill sequence is        complete, the difference between drain fluid weight and patient        fill fluid weight is recorded manually or electronically as        ultrafiltration (“UF”) removed, which can be logged by patient        16 and/or reported to facility professional 18 for storage at        treatment facility 100;    -   (viii) patient collects used CAPD set 190 or 290, used patient        transfer set cap 198 a, and loaded reusable drain container 160,        returns same to front desk 104, and collects a deposit if        posted; and    -   (ix) used CAPD set 190 or 290, used patient transfer set cap 198        a, and loaded reusable drain container 160 are emptied if needed        and disinfected later that day or overnight.

It should be appreciated that in the above scenario, treatment facility100 is completely self-sufficient, requiring no deliveries of pick-ups.The facility need only provide one or more water purification unit, oneor more disposable disinfection unit (e.g., hot water circulation unit),and possibly one or more fill water pre-heating unit. The only wasteproduced is the wrapper for packet 510.

Referring now to FIG. 9, an alternative automated peritoneal dialysis(“APD”) machine embodiment is illustrated. Here, once patient 16 isauthorized or verified at desk 104, patient 16 is allowed to proceed toa further alternative treatment facility 100, in which an APD machine330 is used. APD machines 330 are discussed in detail below inconnection with FIGS. 10 and 12. In FIG. 9, alternative patient stations80 a and 80 b (any number of which could be provided), divided by walls82 a to 82 c are horizontally juxtaposed as opposed to being laid out ina circular manner as is illustrated in FIG. 4. Horizontally juxtaposedAPD patient stations 80 a and 80 b can have any one, or more, or all ofchair, sofa, bed, or the like 34, television 36, remote control 38, deskor table 40, and/or alternating current wall outlet 42 discussed abovein connection with FIG. 4. Station's 80 a and 80 c can be closed using acurtain, wall, and/or door, for example. In the illustrated embodiment,APD patients 16 are provided with beds 34. APD machines 330 are placedadjacent to the beds 34, so that a patient line 320 can extend from aheater or fill bag 314 bag to patient 16.

The APD treatment is discussed below in connection with FIG. 12. Onepoint worth noting here is that APD machines 330 can operate withmultiple supply bags 322. Supply bags 322 may all contain the same kindof dialysate, e.g., DIANEAL™ PD solution. Alternatively, to tailor a PDtreatment, supply bags 322 may contain different kinds of dialysate,e.g., two bags having DIANEAL™ PD solution and a single final bag havingEXTRANEAL™ PD solution. It should also be appreciated that APDtreatments using APD machines 330 with the facilities 100 of the presentdisclosure can use only a single supply bag 322 to perform only a singleexchange, and wherein the single supply bag 322 may be placed atopmachine 330 for heating. In FIG. 9, a heater bag 314, which can be usedwith multiple supply bags, is placed atop a heater pan located at thetop of APD machine 330.

APD patients using machine 330 drain from a cassette, through a drainline 316, to a drain bag 324. APD patients using machine 330 fill from asupply bag 332 into heater bag 314, in which the PD solution is heated,e.g., to thirty-seven° C., and then from heater bag 314 to the patient'speritoneum.

Referring now to FIG. 10, a top plan view shows one possible layout fora facility 100 used in any of the scenarios and settings discussed abovein FIGS. 1 to 6. As discussed above in connection with FIGS. 1 and 2,facility 100 can be located in any suitable type of building, such as astandalone building, building along a busy city street, building in amall, building as part of a larger building, transportation stations andthe like. Facility 100 can also be located at a worksite or within ahousing unit, so that patients can conveniently receive treatmentbefore, during or after work to disrupt their work or home schedules aslittle as possible. Facility 100 can further alternatively be locatedwithin or nearby a housing unit, hostel or other temporary dwellinglocation, to allow residents of the unit or dwelling to receiveconvenient treatment without having to own their own dialysis equipment.Such a facility is especially useful in developing countries in whichmany or most residents do not have access to or the means to havededicated home dialysis equipment. Also, certain countries providetemporary dwelling locations near work, so that employees can live nearwork during the week and return home on the weekend. The facilities ofthe present disclosure can be located at or near any such temporarydwelling location.

Facilities 100 allow the patient to perform exchanges before, duringand/or after work as desired. The patient can for example perform afirst exchange at a facility 100 located between home and work, performa second exchange at a second facility 100 nearer to or at work duringwork, and perform a third exchange returning home from work at theoriginal facility 100. System hub 520 of systems 10 and 110, discussedbelow in connection with FIGS. 14 and 15, enables patient data frommultiple facilities 100 to be collected and analyzed together as if thepatient had used only one facility 100.

As illustrated in FIG. 10 and above in connection with FIGS. 1 to 3,facility 100 includes a door 102 through which patients 16 enter. Oncepatients 16 enter through door 102, the patients approach a desk 104(also illustrated in FIG. 3) to speak with facility professionalsmanning computers 106 a to 106 f. While facility 100 in FIG. 10 showsroom for six facility professionals 18 (FIG. 3) manning six computers106 a to 106 f, facility 100 can instead have any desired number ofcomputers 106 (referring generally to any of computers 106 a to 106 f)and/or facility professionals. For example, in a smaller communitysetting, facility 100 may have only a single computer or professional.Computers 106 can be desktop computers, laptop computers, tablets orhybrid computers/tablets. Mobile laptop computers, tablets and hybridcomputers/tablets enable facility professionals 18 to move aboutfacility 100 and perform multiple functions, such as oversee duties atfront desk 104, work the desks in the different rooms of facility 100,provide care or instructions to the patients, and/or operate a supplyroom. In the illustrated embodiment, computers 106 communicate with aweb portal 524 or 560 (illustrated below in FIGS. 14 and 15) wirelesslyvia wireless transceiver 108.

Once the patient is verified according to any of the methods orprocedures discussed herein, the patient enters a hallway via door 110and proceeds through the hallway until reaching an appropriate, clearlymarked exchange room door 112, 114 or 116. The exchange room accessedvia door 112 is a batch peritoneal dialysis treatment area 200, in whichmultiple peritoneal dialysis patients can be filled off of a same largebatch of a specified type of solution, and which is discussed in detailin connection with FIG. 11. The exchange room accessed via door 114 isan automated peritoneal dialysis (“APD”) machine treatment area 300, inwhich multiple patients each use an in-center APD machine, and which isdiscussed in detail in connection with FIG. 12. The exchange roomaccessed via door 116 is a continuous ambulatory peritoneal dialysis(“CAPD”) treatment area 400, in which multiple patients each use CAPDexchange equipment, and which is discussed in detail in connection withFIG. 13. Facility 100 may have one, or more, or all of batch peritonealdialysis treatment area 200, APD machine treatment area 300, and/or CAPDtreatment area 400. The treatment area(s) of facility 100 may furtheralternatively be a mixture of any combination of treatment areas 200,300 and 400.

FIG. 10 illustrates that batch peritoneal dialysis treatment area 200includes a plurality of larger dialysis solution tanks 210 a, 210 b, 210c and 210 d, which can each hold different dextrose or glucose leveldialysates. Alternatively, the dialysate solution tanks 210 a to 210 dcan hold dialysates that are formulated at low levels of dextrose orglucose or without dextrose or glucose. For example, dialysates withoutglucose are marketed by the assignee of the present disclosure under thetradenames EXTRANEAL™ and NUTRINEAL™. Known and approved dextrose levelsare, e.g., 0% to 4.25%, and known and approved glucose levels are, e.g.,0% to 3.86%.

Batch peritoneal dialysis treatment area 200 also includes a pluralityof common drain areas 250. Alternatively, the patient inside batchperitoneal dialysis treatment area 200 drains to a drain bag orindividual drain. A plurality of sterilizing units 244, such asultraviolet (“UV”) sterilizers, are provided at dialysis solution tanks210 a, 210 b, 210 c and 210 d and common drain areas 250 to allow thepatient to connect and disconnect from each in a sterile manner. Batchperitoneal dialysis treatment area 200 may or may not require a patientdisposable but in any case should produce less disposable waste than APDmachine treatment area 300, and/or CAPD treatment area 400.

Because facility 100 can use hundreds of disposable sets in a singleday, it is desirable to recycle and/or reuse as much of the disposableset as possible. Some portions of the set and/or packaging remain dryand can simply be re-sterilized for reuse. Such disposable portionsinclude, for example, plastic portions that do not contact the effluentdialysate, e.g., caps, plastic bags, paper and cardboard from thepackaging. Any tubing and pumping sections associated with a disposableset that come into contact with fluid however become a biohazard afteruse and are dealt with more carefully. The wet disposable portions canbe collected in a sealed container so as not to contact outsidematerials, preventing the spread of the biohazard. The container istransported to a place in which the wet disposable portion isdisinfected with a chemical sterilizing solution (or other as listedabove) and recycled or reused. The disinfection here takes place in abiohazard environment because there is the potential for exposure tohuman blood which may be infected, for example, by hepatitis or AcquiredImmune Deficiency Syndrome (“AIDS”). If the tubing cannot be disinfectedfor recycling or reuse, it is instead packaged, labeled as a biohazardand given to a licensed biohazardous waste hauler.

Likewise, any used dialysate or fluid that cannot be recycled or reusedis also disposed as a biohazard. CAPD patients often dispose of effluentdialysate by pouring the fluid into a sewage system. Facility 100however may disinfect the used dialysate before discarding it becausethe facility may be disposing of hundreds of liters of used dialysateevery day. Particular care is taken to ensure that the disposal of anybiohazard materials complies with Control of Substances Hazardous toHeath (“COSHH”), Occupational Safety and Health Administration (“OSHA”)and Environmental Protection Agency (“EPA”) regulations.

When the patient enters batch peritoneal dialysis treatment area 200,the patient approaches desk 120 a and hands an attendant an orderreceived from one of the computers 106 at front desk 104. Or, the orderis sent from one of the front desk computers 106 a to 106 f to treatmentarea 200 computer 106 g. Further alternatively, facility professional 18walks the patient from the front desk area to batch peritoneal dialysistreatment area 200 and enters the patient's order, e.g., via theprofessional's mobile laptop computer, tablet or hybrid computer/tablet.In any case, the order is entered for billing purposes at this time. Thepatient may or may not be charged a co-pay amount at front desk 104. Ifthere is any disposable that is needed for the treatment at batchperitoneal dialysis treatment area 200, a facility professional 18 pullsthe disposable from behind treatment area desk 120 a or enters astoreroom 150 through door 122 to obtain the disposable. Again thepatient at batch peritoneal dialysis treatment area 200 may not need anydisposable.

If the patient in batch peritoneal dialysis treatment area 200 iscurrently full of used dialysis fluid, the patient connects to one ofcommon drain areas 250 via the patient's transfer set. Such connectioncan be made with sterilizing unit 244 and/or with a cleaning agent suchas rubbing alcohol. The patient then drains the used fluid, e.g., in asitting position, to allow for as complete a drain as possible. Afterdrain, the patient proceeds to a designated dialysis solution tank 210a, 210 b, 210 c or 210 d for filling. The patient again connects his orher transfer set to the designated solution tank, e.g., usingsterilizing unit 244 and/or with a cleaning agent such as rubbingalcohol. The patient then performs a peritoneal dialysis fill procedure,which is explained in more detail in connection with FIG. 11.

The patient can wait for a dwell period and perform the above exchangeagain, and if desired do so multiple times. Or, the patient may do thesingle exchange and then leave facility 100. While in batch peritonealdialysis treatment area 200, the patient can watch television, e.g., viatelevision 118 a, work on the patient's computer, read, or connect tothe Internet via wireless transceiver 108. It is contemplated for thepatient to weigh himself or herself at a weigh scale 130 and to take hisor her blood pressure at blood pressure cuff 132, e.g., with theassistance of a facility professional 18. Either or both patient weightand blood pressure may be recorded before drain, and/or after drain,and/or after fill. The same recording can be done for glucose monitoringof the patient. The patient may record the readings and give them to theprofessional, the professional may record the readings, or the readingsmay be sent wirelessly from weigh scale 130 and/or pressure cuff 132 totreatment area computer 106 g or to a front desk computer. All treatmentdata, such as patient weight, blood pressure, glucose level, drainamount(s) and fill amount(s), is recorded and logged. The patient datacan be sent to the patient's clinic or hospital 522 a, 522 b or 522 c(FIGS. 14 and 15). One clinician system for receiving and trackingperitoneal dialysis patient data is illustrated and described in U.S.patent application Ser. No. 13/828,900, entitled, “Home Medical DeviceSystems And Methods For Therapy Prescription And Tracking, Servicing AndInventory”, filed, Mar. 14, 2013, the entire contents of which areincorporated herein by reference and relied upon.

It is contemplated that larger dialysis solution tanks 210 a, 210 b, 210c and 210 d be tanks of sterilized fluid, e.g., rigid plastic orstainless steel tanks, which are removed through storeroom 150 via door122 when the tanks are empty and replaced with a full tank 210 storing adialysate of the same dextrose or glucose level from storeroom 150. Theempty tanks 210 are shipped to the factory, sterilized for example usingethylene oxide while empty, and then are filled under a controlled andsterile manner with sterilized dialysis fluid of a desired dextrose orglucose level, after which the refilled tanks 210 can be shipped back toa facility 100. In an alternative embodiment, larger dialysis solutiontanks 210 a, 210 b, 210 c and 210 d are left in place inside batchperitoneal dialysis treatment area 200, sterilized when emptied, e.g.,via ethylene oxide, and then refilled onsite in a sterilized manner withsterilized dialysis fluid of a desired dextrose or glucose level. Thetanks 210 inside storeroom 150 can therefore be even larger steriletanks for refilling tanks 210 a, 210 b, 210 c and 210 d located withinbatch peritoneal dialysis treatment area 200.

It is also contemplated that a facility 100 can include an onsitesorbent system for regenerating effluent dialysate into useabledialysate. Such a sorbent system removes undesirable components in theeffluent dialysate that have been obtained from the patient (e.g.,toxins, fibrin and metabolic wastes). The sorbent system can also adddesirable components (e.g., dextrose, glucose) and electrolytes (e.g.,potassium, calcium) to reconstitute the dialysate and maintain a desiredosmotic gradient for the removal of ultrafiltration from the patient.One known sorbent system uses a sorbent cartridge that absorbs uremictoxins such as urea, creatinine, uric acid and other metabolismby-products. As the effluent dialysate passes through the sorbentcartridge, undesirable components are removed from the dialysate and thedialysate emerges useable for additional treatment. Infusate is thenpumped into the cleansed dialysate to add salts and/or sugars as needed.Suitable sorbent systems and corresponding methods are set forth in U.S.Pat. No. 7,208,092, entitled, “Systems and Methods for PeritonealDialysis”; U.S. Pat. No. 7,867,214, entitled, “Systems and Methods forPerforming Peritoneal Dialysis”; and U.S. Pat. No. 7,922,686, entitled,“Systems and Methods for Performing Peritoneal Dialysis”, the entirecontents of each of which are incorporated herein by reference andrelied upon.

The sorbent system can be installed at facility 100, so that a largebatch of effluent dialysis fluid removed from multiple patients isregenerated at one time. Alternatively, the sorbent system is configuredso that the effluent dialysate is regenerated immediately andindividually as it is removed from each patient. Using a sorbent systemto regenerate effluent dialysate collected by the facility 100 reducesthe amount of fresh dialysate that needs to be shipped to and stored byfacility 100. The use of such a sorbent system also reduces the amountof waste fluid that facility 100 needs to address and discard as hasbeen discussed above.

Alternatively or in addition to sorbent regeneration, facility 100 canprovide other forms of effluent cleaning for regeneration, such as anyone or more of electrodialysis (“ED”), electrodialysis reversal (“EDR”),electrodeionization (“EDI”), ultrafiltration, reverse osmosis filtering,ultraviolet radiation, or ozone. Ozone can be created online bysubjecting oxygen to ultraviolet light. The ozone can then be drawn intothe effluent dialysate stream, e.g., via a venture pump. Ozone tends notto store well under positive pressure.

It is further contemplated that a facility 100 can include a waterpurification system to reuse at least a portion of the water separatedfrom the effluent dialysate. Even if the effluent dialysate is notregenerated into useable dialysate, removing and purifying water fromthe effluent dialysate can reduce the volume of waste fluid requiringdisposal. Additionally, the purified water can be used for otherapplications at facility 100, including the preparation of freshdialysate made online or at the time of use. In addition to purifyingwater separated from effluent dialysate, the water purification systemcan be installed so as to receive tap water, purify the tap water, anduse the purified tap water to prepare dialysate online using eitherfresh concentrates or in combination with the sorbent system describedabove. One suitable water purification system is set forth in U.S.Patent Publication No. 2011/0197971, entitled, “Water PurificationSystem and Method”, filed Apr. 25, 2011, the entire contents of whichare incorporated herein by reference and relied upon. In one embodiment,the purification system includes filters to purify tap water (e.g.,remove pathogens and ions such as chlorine) so that the water ispreferably below 0.03 endotoxin units/ml (“EU/ml”) and below 0.1 colonyforming units/ml (“CFU/ml”).

Referring again to FIG. 10, when the patient enters APD machinetreatment area 300, the patient approaches desk 120 b and hands anattendant an order received from one of the computers 106 at front desk104. Or, the order is sent from one of the front desk computers 106 a to106 f to treatment area 300 computer 106 h. Further alternatively,facility professional 18 walks the patient from the front desk area toAPD machine treatment area 300 and enters the patient's order, e.g., viathe professional's mobile laptop computer, tablet or hybridcomputer/tablet. In any case, the order is entered for billing purposesat this time, which again may include a co-pay amount at front desk 104.APD machine treatment stations 310 a to 310 j of APD machine treatmentarea 300 each use a disposable set 312 operable with an APD machine 330,which is illustrated in detail below in connection with FIG. 12. Thefacility professional pulls the disposable set 312 from behind treatmentarea desk 120 b or enters storeroom 150 through door 124 to obtaindisposable set 312. One suitable APD machine is the HomeChoice™ orHomeChoicePro™ machine provided by the assignee of the presentdisclosure.

If the patient in APD machine treatment area 300 is currently full ofused dialysis fluid, the patient connects to one of common drain areas250 via the patient's transfer set, which as before can be made with asterilizing unit 244 and/or with a cleaning agent such as rubbingalcohol. The patient then drains the used fluid, e.g., in a sittingposition, to allow for as complete a drain as possible. A drain canalternatively be done automatically, in which APD machine 330 pumpsspent fluid from the patient to a drain bag provided as part ofdisposable set 312. After drain, the patient proceeds to (or is alreadyat) a designated APD machine treatment station 310 a to 310 j forfilling. Unlike with batch peritoneal dialysis treatment area 200, thedisposable set 312 will be provided with a fill bag(s) having thepatient's prescribed dextrose or glucose level dialysate and theprescribed fill volume. Thus, the particular APD machine treatmentstation 310 a to 310 j upon which the patient runs treatment may not beimportant as long as the machine can accept and operate the disposablecassette 312 given to the patient. There may be different versions ofmachines 330 at stations 310 a to 310 j, and the patient may prefer aparticular version or machine 330 for programming or user interfacereasons, for example. The patient connects his or her transfer set todisposable set 312 in a sterile manner, e.g., using a sterilizing unit244 and/or with a cleaning agent such as rubbing alcohol. The patientcan be allowed to load the disposable set 312 into the APD machine 330,program treatment, and execute treatment. In the alternative, one of thefacility professionals may assist the patient with any one, or more, orall of loading the disposable set 312, programming treatment, and/orexecuting treatment. Once disposable set 312 is loaded into APD machine330, the machine 330 then performs an automated peritoneal dialysis fillprocedure, which is explained in more detail below.

As with the batch treatment, the patient in APD treatment area 300 canwait for a dwell period and perform the above exchange again, and ifdesired do so multiple times. Or, the patient may do the single exchangeand then leave facility 100. While on a machine 330, the patient canwatch television, e.g., via television 118 b, work on the patient'scomputer, read, or connect to the Internet via wireless transceiver 108.As before, it is contemplated for the patient to weigh himself orherself at a weigh scale 130 and/or to take his or her blood pressure atblood pressure cuff 132, e.g., with the assistance of a facilityprofessional 18. Either or both patient weight and blood pressure may berecorded before drain, and/or after drain, and/or after fill. The samerecording can be done for glucose monitoring of the patient. Alltreatment data, such as patient weight, blood pressure, glucose level,drain amount(s) and fill amount(s) can again be recorded, logged andsent to the patient's clinic or hospital 22 a, 22 b or 22 c.

Storeroom 150 includes spare APD machines 330 and disposable sets 312.Storeroom 150 also stocks spare disposable sets 412 for the stations 410a to 4101 of continuous ambulatory peritoneal dialysis (“CAPD”)treatment area 400 discussed next. And for any of the treatment areas200, 300 and 400, storeroom 150 stocks spare sterilizing units 244,weight scales 130, blood pressure cuffs 132, glucose monitors (notillustrated) and other desired equipment. Suitable sterilizing units aredescribed in U.S. patent application Ser. No. 11/773,623, entitled,“Peritoneal Dialysis Patient Connection System”, filed Jul. 5, 2007, andU.S. patent application Ser. No. 11/773,824, entitled, “PeritonealDialysis Patient Connection System Using Ultraviolet Light EmittingDiodes”, filed Jul. 5, 2007, the entire contents of each of which areincorporated herein by reference and relied upon.

When the patient instead enters CAPD treatment area 400, the patientapproaches desk 120 c and hands an attendant an order received from oneof the computers 106 at front desk 104. Or, the order is sent from oneof the front desk computers 106 a to 106 f to treatment area 400computer 106 i. Further alternatively, the facility professional walksthe patient from the front desk area to APD machine treatment area 400and enters the patient's order, e.g., via the professional's mobilelaptop computer, tablet or hybrid computer/tablet. In any case, theorder is entered for billing purposes at this time, which again mayinclude a co-pay amount at front desk 104. CAPD treatment stations 410 ato 410 l of CAPD treatment area 400 each use a disposable set 412, whichis operated manually by a patient. The facility professional pulls adisposable set 412 from behind treatment area desk 120 c or entersstoreroom 150 through door 124 to obtain disposable set 412.

If the patient in CAPD treatment area 400 is currently full of useddialysis fluid, the patient can connect to one of common drain areas 250via the patient's transfer set, which as before can be made with asterilizing unit 244 and/or with a cleaning agent such as rubbingalcohol. A drain can alternatively be done manually, in which thepatient gravity feeds spent fluid from the patient to a drain bagprovided as part of disposable set 412. The patient then drains the usedfluid, e.g., in a sitting position, to allow for as complete a drain aspossible. After drain, the patient proceeds to (or is already at) adesignated CAPD treatment station 410 a to 410 l for filling. Unlikewith batch peritoneal dialysis treatment area 200, the disposable set412, like disposable set 312, will be provided with a fill bag(s) havingthe patient's prescribed dextrose or glucose level dialysate and theprescribed fill volume. Thus, the particular CAPD treatment station 410a to 410 l at which the patient runs treatment is not important. Thepatient likely connects himself or herself to disposable set 412 fortreatment. In the alternative, one of the facility professionals mayassist the patient with connecting to disposable set 412. The patientconnects his or her transfer set to disposable set 412 in a sterilemanner, e.g., using a sterilizing unit 244 and/or with a cleaning agentsuch as rubbing alcohol. The patient then performs a manual peritonealdialysis fill procedure, which is explained in more detail below.

As an alternative to storing dialysate with predetermined levels ofglucose and dextrose, a proportioned solution may be produced on demandat the facility. In one embodiment, facility 100 can include separatecontainers of fresh dialysate, water and other concentrates or solutionscontaining desirable components in liquid form, such as glucose,dextrose and electrolytes. Alternatively, the use of dry chemicals orconcentrated chemical reagents as an alternative to liquid concentratescan be used and reduce the space necessary for storing the concentrates.Facility 100 mixes the dialysate, water, salt, concentrates and/or otherchemicals and solutions on demand based on each patient's prescription.For example, one method of producing fresh dialysate is by mixing anacid concentrate with a bicarbonate concentrate and then diluting theresulting mixture with water. In this example, the acid concentrates canbe stored in separate ionic concentrations, and the bicarbonateconcentrates can be stored as sodium bicarbonate and/or sodiumbicarbonate mixed with sodium chloride. The concentrates can then bemixed onsite to prepare fresh dialysate according to a patient'sspecific prescription. Mixing the dialysate onsite allows facility 100to reduce the amount of disposable packaging that is consumed via theuse of premixed dialysates. Instead, dialysate can be prepared as neededusing larger containers of concentrate liquids and/or chemicals forpreparing dialysate online. One suitable system and method for mixingperitoneal dialysis solutions is set forth in U.S. Pat. No. 5,925,011,entitled, “System and Method for Providing Sterile Fluids for AdmixedSolutions in Automated Peritoneal Dialysis”, the entire contents ofwhich are incorporated herein by reference and relied upon. The mixeddialysate solution can be provided to the patient, for example bydispensing the liquid into a heating/weighing bag provided to thepatient for dialysis treatment.

As with the treatments of areas 200 and 300, the patient in CAPDtreatment area 400 can wait for a dwell period and perform the aboveexchange again, and if desired do so multiple times. Or, the patient maydo the single exchange and then leave facility 100. While at a treatmentstation 410 a to 410 l, the patient can watch television, e.g., viatelevision 118 c, work on the patient's computer, read, or connect tothe Internet via wireless transceiver 108. As before, it is contemplatedfor the patient to weigh himself or herself at a weigh scale 130 and totake his or her blood pressure at blood pressure cuff 132, e.g., withthe assistance of a facility professional 18. Either or both patientweight and blood pressure may be recorded before drain, and/or afterdrain, and/or after fill. The same can be done for glucose monitoring ofthe patient. All treatment data, such as patient weight, blood pressure,glucose level, drain amount(s) and fill amount(s) can again be recordedand logged and sent to the patient's clinic or hospital 22 a, 22 b or 22c.

Facility Treatment Areas

Referring now to FIG. 11, one embodiment for batch peritoneal dialysistreatment area 200 discussed above is illustrated. Batch peritonealdialysis treatment area 200 dispenses specific amounts of a prescribedtype of dialysis solution. Batch peritoneal dialysis treatment area 200can be a portion of a treatment facility 100 discussed above andincludes larger dialysis solution tanks 210 a, 210 b, 210 c . . . 210 n,which are multi-treatment containers of different, select peritonealdialysis solutions, such as ones having the glucose or dextrose levelslisted above. For example, each tank 210 a, 210 b and 210 c can containa different dialysis solution 212 a, 212 b and 212 c, e.g., having adifferent dextrose level, e.g., 1.5%, 2.5% and 4.25% dextrose or glucoselevel, e.g., 1.36%, 2.27% and 3.86% glucose, which are known andapproved levels.

Tanks 210 a to 210 c can be stainless steel or plastic and in anembodiment are capable of being sterilized, e.g., via ethylene oxidesterilization. Tanks 210 a to 210 c can have integrated castors fortransport or can be tilted for loading onto and off of a rolling palletor forklift for transport. Tanks 210 a to 210 c in the illustratedembodiment are each provided with a heater 214, such as a radiantinfrared or ultraviolet heater that connects to a glass or other radiantwave permeable window or section of the tank. Heater 214 canalternatively be a resistance heater (not illustrated) upon which thetank sits. In either case, heater 214 receives power or duty cyclesignals from a control unit 215. Control unit 215 can for example be amicrocontroller (e.g., contain processing and memory) located in a boxwith heater 214. A temperature sensor 216, such as a thermocouple orthermistor, is placed inside each tank 210 a to 210 c and detects andfeeds a temperature signal to the microcontroller for temperature, e.g.,duty cycle, control of the dialysis fluid. The microcontroller can beconnected to a wireless modem that links wirelessly via transceiver 108to batch area computer 106 g and/or one of front desk computers 106 a to106 f.

There may also be an analog output liquid level sensor 218, such as anultrasonic or laser sensor provided at the top of the tank, whichdetects and sends a signal indicative of a level of dialysate insidetanks 210 a to 210 c to the microcontroller housed inside the enclosurefor heater 214. Liquid level or volume can be ascertained alternativelyby providing a weigh scale (not illustrated) beneath each tank 210 a to210 c. The weigh scale can itself send a wireless weight signal to batcharea computer 106 g and/or one of front desk computers 106 a to 106 f inone embodiment. In these embodiments, the dialysate temperature andlevel (or volume) within each tank 210 a to 210 c can be monitoredremotely. Software at the remote computer can also be provided to informthe facility professional of when a tank 210 a to 210 c will soon needto be switched out or refilled.

It is also contemplated to make tanks 210 a to 210 c out of asemi-translucent material, such as a semi-translucent plastic, so thatthe dialysis fluid level within the tank can be viewed from outside ofthe tank. Also, each tank 210 a to 210 c can be provided with ahydrophobic or high-efficiency particulate air (“HEPA”) filter 219,e.g., at the top of the tank, to let filtered air into the tank todisplace consumed dialysate, so that negative pressure does not buildwithin the tank.

In the illustrated embodiment, each tank 210 a to 210 c is provided witha plurality of peritoneal dialysis supply dispensers, e.g., dispensers220 a to 220 f. Dispensers 220 a to 220 f may be attached, e.g.,foldably attached, to tank 210 a to 210 c. In this manner, dispenserstravel with the tanks for sterilization, testing and repair.Alternatively, dispensers 220 a to 220 f are shipped to facility 100individually in sterilized bags (not illustrated), stored in storeroom150, removed from the sterilized bag and connected when needed to one ofthe tanks 210 a to 210 c in a sterile manner, e.g., using a sterilizingunit 244 and/or a sterilization cleaning agent such as alcohol.

Dispenser 220 a of tank 210 a illustrates one embodiment for thedispensers in detail. Dispenser 220 a includes a supply line 222, apressure regulator 224 that controls downstream pressure, a meteringdevice fill valve 226, a metering device 228, a metering device dispelvalve 232, and a flexible line 234 leading flexibly to a check valve 236and a dispenser connector 238. Dialysis fluid in tanks 210 a to 210 c isgravity fed to the patient. The large amount of dialysis fluid heldwithin the tanks can create a large head pressure. Pressure regulator224 causes the pressure of the dialysis fluid downstream of theregulator to be within a more manageable range, e.g., five to ten psig.

Metering device 228 includes liquid level sensors 230 a and 230 b, whichcan operate as an emitting and receiving pair, e.g., light or laseremitting and receiving. Liquid level sensors 230 a and 230 b are movedup and down along the scale of metering device 228 by patient 16 orfacility professional 18 to the prescribed fill level. Although notillustrated, a ball screw type of translating apparatus can be providedwith metering device 228, which translates liquid level sensors 230 aand 230 b in a precise manner via a manual or motorized turning of thescrew to the prescribed fill level. To fill metering device 228, dispelvalve 232 is closed, while fill valve 226 is opened, so that liquidunder a manageable pressure and corresponding flowrate fills themetering tube.

Control unit 215 is programmed such that when the dialysis fluid fillsthe metering tube so that its level obstructs the beam of light orenergy running from liquid level sensor 230 a to sensor 230 b, fillvalve 226 is closed. Valves 226 and 232 and liquid level sensors 230 aand 230 b are controlled electrically via the tank's control unit 215 inthe illustrated embodiment. It is also contemplated to place a filteredair port (not illustrated), like filters 219, at the top of meteringdevice 228, so that pressure does not build within the tube of meteringdevice 228 and so that any air entering supply line 222 from tank 210 aand 210 c is purged under pressure to the top of or out though the topof metering device 228.

To fill the patient from metering device 228, fill valve 226 remainsclosed, while dispel valve 232 is opened. Fluid is gravity fed under asafe low pressure through dispel valve 232, flexible line 234, checkvalve 236 and connector 238, through the patient's transfer set 242 andinto patient 16 via the patient's indwelling, implanted catheter. Priorto fluid delivery, the patient makes a sterile connection of thepatient's transfer set 242 to dispenser connector 238, e.g., via asterilization unit 244 and/or an antiseptic cleaning agent, such asrubbing alcohol. Check valve 236 prevents any patient fluid from movinginto supply line 222. Also, supply line 222 remains fully primed betweenuses. Dispenser connector 238 is configured such that no fluid can exitsupply line 222 through check valve 236 unless patient transfer set 242is mated to dispenser connector 238. To this end, dispenser connector238 may be provided with an on/off valve (not illustrated). Dispenserconnector 238 may also have a disposable tip (not illustrated) that isreplaced with a sterilized tip prior to each use.

Metering device 228 can alternatively include other apparatuses capableof monitoring and metering the flow of dialysis solution to meet theamount of dialysis solution 212 a to 212 c predetermined by thepatient's prescription. In one alternative embodiment, metering device228 includes an integrated flowmeter that monitors and integratesdialysate flowrate versus time to determine when the patient hasreceived the prescribed amount of dialysis solution.

In another alternative embodiment, metering device 228 includes abalance chamber that has a known and fixed volume chamber, which isdivided by a membrane or diaphragm that flaps back and forth betweeninner walls of the chamber separated by the membrane or diaphragm.Pressurized dialysate flowing from tanks 210 a to 210 c is split intotwo inlet lines, each leading to different sides of the membrane. Eachinlet line is valved. The valves are sequenced to drive dialysate intothe chamber from alternating sides of the membrane, each time driving alike volume of dialysate out of the chamber on the other side of themembrane towards the patient. Thus there are also two outlet lines, oneon each side of the membrane or diaphragm, leading from the chambertowards the patient, each outlet line also being valved, wherein thevalves of the outlet lines are sequenced in sync with the valves of theinlet lines, and wherein the inlet valve on one side of the membrane isopened and closed with the outlet valve on the other side of themembrane and vice-versa. The valved outlet lines are teed together toform a single outlet line forming or leading to flexible line 234, checkvalve 236, connector 238 and patient 16. Control unit 215 counts orknows how many times the valves are sequenced. That number multiplied bythe known volume of the chamber provides an ever-increasing total volumepumped to the patient. When the actual total volume pumped equals theprescribed total volume, the exchange fill is completed and the balancechamber valves are closed. Here, the prescribed total volume can beentered electronically into control unit 215 of tanks 210 a to 210 c via(i) a user interface or keypad provided with dispensers 220 a to 220 for (ii) the computer, tablet, or hybrid computer/tablet of one of thefacility professionals, which is in wireless communication with controlunit 215.

In many instances, patient 16 will enter batch peritoneal dialysistreatment area 200 with used dialysis solution in his or her peritoneumthat first needs to be drained. To do so, patient 16 can connect firstto (i) a drain bag (not illustrated), which can then be weighed and/orsampled and then discarded or (ii) an individual drain (notillustrated). In the illustrated embodiment, however, patient 16 caninstead drain to a common drain area 250 discussed above in connectionwith FIG. 10. Common drain area 250 includes a tank or basin 252. Aplurality of valved drain line assemblies 254 a to 254 g extend off oftank or basin 252. Each valved drain line assembly 254 a to 254 gincludes a three-way valve 256 that allows the drain fluid to floweither from patient 16 to a reusable weigh bag or container 258 or fromweigh bag or container 258 to tank or basin 252. In an embodiment, noposition of valve 256 allows fluid to flow from patient 16 to drain tankor basin 252, which forces the patient to drain to weigh bag orcontainer 258. The patient connects to valve 256 via sterilization unit244 and/or via an antiseptic agent as has been discussed above.

As illustrated, each weigh bag or container 258 sits on a scale 260.Scale 260 can send the patient's drain weight wirelessly via transceiver108 to a computer 106 a to 106 g, which then logs the drain volume alongwith other exchange data discussed above for sending to the patient'sclinic 22 a to 22 c. The effluent weight data transfer to a computer 106a to 106 g is done alternatively manually as has been discussed herein.In an embodiment, weigh bag or container 258 is provided with a sampleport (not illustrated), which allows an effluent sample to be taken,which can be given to a facility professional 18, e.g., at batch areadesk 120 a or front desk 104 for analysis that can be performed whilepatient 16 is performing his or her exchange. The results can be givento the patient upon leaving facility 100 and/or logged as part of theexchange data sent to the patient's clinic 22 a to 22 c. Althoughweighing the drained dialysate to track the patient's drain volume isdesired for patient volume and ultrafiltration control, it iscontemplated that not every facility 100 will have the means orresources for weighing drained dialysate. In such cases, a patient caninstead drain effluent dialysate into a common drain without suchweighing.

After the patient's drain to weigh bag or container 258 is complete, itis contemplated that the patient or facility professional 18 lift thebag or container 258 to, e.g., a hook or ledge provided by tank or basin252, located elevationally above both valve 256 and the connection ofthe respective drain line 254 a to 254 g to the tank or basin. Theposition of valve 256 is then switched so that the patient's effluentcan gravity flow from weigh bag or container 258 to tank or basin 252.Tank or basin 252 is configured and arranged to efficiently andeffectively handle biowaste, such as used dialysate from the patient'speritoneum.

Referring now to FIG. 12, one embodiment for an APD machine peritonealdialysis treatment area 300 discussed above is illustrated. APD machineperitoneal dialysis treatment area 300 dispenses specific amounts of aprescribed type of dialysis solution and can be a portion of a treatmentfacility 100 as discussed above. Treatment area 300 includes APD machinetreatment stations 310 a to 310 d, which each provide a disposable set312 operable with an APD machine 330. Each disposable set 312 cancontain a different dialysis solution, e.g., having a different dextroselevel, e.g., 1.5%, 2.5% and 4.25% dextrose or glucose level, e.g.,1.36%, 2.27% and 3.86% glucose, which are known and approved levels.Each disposable set 312 can also contain a specified volume of theprescribed type of dialysate. Or, disposable set 312 can contain moredialysate than the prescribed volume and rely on APD machine 330 to pumpthe prescribed volume of dialysate to patient 16.

Disposable set 312 may contain a single dialysate fill bag 314 only.Here, the patient can drain to a common drain area 250 as has beendiscussed above in connection with FIGS. 10 and 11, including allalternatives discussed in connection with those figures. When thepatient drains to common drain area 250, disposable set 312 does notneed a drain bag or associated drain line or tube. Alternatively,disposable set 312 does include a drain bag that attaches to a drainline 316, allowing APD machine 330 to perform the drain automaticallyfor the patient. Still further alternatively, APD machine 330 pumpspatient effluent to an individual drain via drain line 316.

In the illustrated embodiment, dialysate fill bag 314 is placed on aheater 332 located at the top of APD machine 330. Heater 332 heats thedialysate within fill bag 314 to at or near the patient's bodytemperature, e.g., about 37° C. It is expressly contemplated however topreheat fill bag 314 as part of disposable set 312 stored in storeroom150 to reduce or even eliminate heating time before the patient's fillcan begin. A tube 318 carries heated dialysate pumped from fill bag 314into and by a disposable pumping cassette that has been loaded into APDmachine 330 and thus cannot be viewed in FIG. 12. One suitabledisposable pumping cassette is illustrated and described in U.S. Pat.No. 5,989,423, the entire contents of which are incorporated herein byreference and relied upon. APD machine 330 then pumps heated dialysateout of the cassette, through patient line 320, to patient 16. APDmachine 330 via the disposable pumping cassette can pump a precise fillvolume of the prescribed dialysate to the patient's peritoneum. Theprescribed volume is entered into the control unit (not illustrated butincluding processing and memory) of APD machine 330 by the patient orfacility professional 18 manually in one embodiment via a user interface334. Alternatively, the facility professional enters the prescribed fillvolume into the control unit (processing and memory) of APD machine 330remotely and wirelessly via the facility professional's laptop computer,tablet or hybrid computer/tablet.

For a single exchange, once the prescribed fill from fill bag 314 ispumped to patient 16, the patient can disconnect from machine 330 andleave facility 100. For multiple fills, the patient can remain connectedto machine 330 or disconnect from machine 330 but remain physicallyclose to (e.g., within one-half hour of) machine 330, while the solutionfrom fill bag 314 dwells within the patient's peritoneum, removingtoxins and ultrafiltrate (“UF”). Once a prescribed dwell period hasended, machine 330 automatically pulls the used effluent dialysate fromthe patient into and by the disposable pumping cassette, which in turnpumps the effluent dialysate to drain via drain line 316.

Disposable set 312 may accordingly include one or more additional supplybags 322 to allow the drain and fill procedure to be repeated one ormore time. Machine 330 records all fill volumes and drain volumes forlogging and delivery to the patient's clinic 22 a to 22 c via any dataflow manner described herein. One or more additional supply bag 322 cancontain a different type of dialysate than initial fill bag 314. Forexample a last fill supply bag 322 may contain a dialysate prescribedfor remaining in the patient's peritoneum after the patient has leftfacility 100.

Referring now to FIG. 13, one embodiment for a CAPD peritoneal dialysistreatment area 400 discussed above is illustrated. CAPD peritonealdialysis treatment area 400 likewise dispenses specific amounts of aprescribed type of dialysis solution and can be a portion of a treatmentfacility 100 as discussed above. Treatment area 400 includes CAPDtreatment stations 410 a to 410 d, which each provide a disposable set412 that is operated manually by the patient typically. Each disposableset 412 can contain a different dialysis solution, e.g., having adifferent dextrose level, e.g., 1.5%, 2.5% and 4.25% dextrose or glucoselevel, e.g., 1.36%, 2.27% and 3.86% glucose, which are known andapproved levels. Each disposable set 412 can also contain a specifiedvolume of the prescribed type of dialysate. Or, disposable set 412 cancontain more dialysate than the prescribed volume and rely on thepatient to meter the prescribed fill volume of dialysate.

Disposable set 412 in the illustrated embodiment is a twin-bag CAPD set,which uses three clamps 414 a, 414 b and 414 c to perform the CAPDtreatment. Clamp 414 a is mounted to a first tube 416, which connects tothe patient's transfer set 242 (FIG. 11), which in turn runs to acatheter implanted in the body of a patient. Clamp 414 b is mounted to asecond tube 418, which is connected at one end to a Y-shaped joint 420joined to the other end of first tube 416. Second tube 418 is connectedat its other end to a dialysis fluid bag or container 422 for supplyingthe prescribed amount and type of dialysate to the patient. Clamp 414 bis mounted to a third tube 424 connected at one end to a drain bag 426for collecting and discarding the patient's used effluent dialysate.

When the patient is initially full of spent effluent, the patient opensvalves 414 a and 414 c to gravity drain to drain bag 426. To flush thesystem of drain fluid, the patient then opens valves 414 b and 414 c toallow a small amount of fresh fluid to gravity flow to drain, flushingand priming second tube 418. The patient then refills with freshdialysate by opening valves 414 a and 414 b to allow fresh fluid togravity feed to the patient. Disposable set 412 can alternativelyreplace separate valves 414 a to 414 c with a single multi-positionvalve that connects to Y-shaped joint 420 and provides multiple manuallyset positions to perform each of the draining, flushing and fillingsteps.

Multiple disposable sets 412 may be provided to the patient for multipleexchanges. In any case, the patient can alternatively drain to a commondrain area 250 or to an individual house drain as has been discussedabove in connection with FIGS. 10 and 11, including all alternativesdiscussed in connection with those figures. When the patient drains tocommon drain area 250 or house drain, disposable set 412 needs only asingle line 416 connected at a patient end to valve 414 a and at theother end to solution bag 422. Single line 416 can be packagedpre-primed up to valve 414 a, eliminating the flushing step. As with APDset 312, solution bag 422 of CAPD set 412 can be pre-warmed to at ornear the patient's body temperature, e.g., about 37° C. in storeroom 150to reduce or even eliminate heating time before the patient fill canbegin.

For a single exchange, once the prescribed fill from fill bag 422 isgravity fed to patient 16, the patient can disconnect from set 412 andleave facility 100. For multiple fills, the patient can remainphysically close to (e.g., within one-half hour of) facility 100, whilethe solution from fill bag 422 dwells within the patient's peritoneum,removing toxins and ultrafiltrate (“UF”). Once a prescribed dwell periodhas ended, the patient drains to drain bag 426 using a second disposableset 412, to community drain 250 or to another house drain as discussedabove, and performs another fill with a second supply bag 422.

Facility 100 records all fill volumes and drain volumes for logging anddelivery to the patient's clinic 22 a to 22 c via any data flow mannerdescribed herein. One or more additional supply bag 422 can contain adifferent type of dialysate than the initial fill bag 422. For example alast fill supply bag 422 may contain a dialysate prescribed forremaining in the patient's peritoneum after the patient has leftfacility 100.

Facility System Architecture

FIGS. 14 and 15 illustrate various embodiments for integrating thefacilities described above into a larger system. Also illustrated arevarious methods for operating the facilities of the present disclosure.In FIG. 14, peritoneal dialysis system 10 includes peritoneal dialysisexchange facilities 100 a, 100 b and 100 c, which can access electronicmedical record databases 522 a, 522 b and 522 c via system hub 520 andweb portal 560. In FIG. 12, peritoneal dialysis system 110 includesperitoneal dialysis exchange facilities 100 a, 100 b and 100 c, whichcan access electronic medical record databases 522 a, 522 b and 522 cvia web portal 524. The primary difference between the two systems isthat in system 10 of FIG. 14, web portal 560 accessed via dialysisexchange facilities 100 a, 100 b and 100 c is provided by the sameentity that provides and supports the patient's home machine, e.g., themachine, solution and disposable supplier (“machine supplier”). Here,facilities 100 a, 100 b and 100 c may be primarily owned and operated bythe machine supplier. In system 110 of FIG. 15, on the other hand, webportal 524 is hosted by a different entity, e.g., by one of the clinicsthat work with the machine supplier. There may be more than onedifferent entity or clinic operating with system 110, each entityhosting their own web portal 524. For example, Clinic A, working withthe machine supplier may service one portion of a country in which themachine supplier operates, while Clinic B, working with the machinesupplier services another portion of the country, and so on. Here,facilities 100 a, 100 b and 100 c may be primarily owned and operated bythe clinics or companies other than the machine supplier.

In systems 10 and 110, exchange facilities 100 a, 100 b and 100 c arewalk-in facilities in which a peritoneal dialysis patient can receiveperitoneal dialysis treatment at the location. Each facility 100 in anembodiment receives a prescription from a patient and verifies that thepatient has been prescribed a peritoneal dialysis treatment by alicensed physician. In one embodiment, a repeat patient can be stored inthe computers of the facility, such that the patient can identifyhimself or herself, be accessed from a database, and perform treatmentwithout having to bring his or her prescription to the facility. Thepatient's prescription sets forth a plurality of treatment parameters,such as type of treatment (e.g., APD versus CAPD), number of exchangesper treatment, and volume and type of solution for each exchange.Different dialysis solutions contain different compositions of dextroseor glucose, salt and other constituents. Glucose or dextrose controlsthe osmotic gradient provided by the dialysate, which in turn controlshow much or how quickly excess fluid is pulled from the patient's bodyand into the peritoneum as ultrafiltrate (“UF”). The higher the dextroselevel, the higher the UF ability of the solution, but also the higherthe caloric intake of the solution. Patients may need more or lessglucose or dextrose for longer dwell time exchanges, such as for middayexchanges. Electrolytes such as potassium and calcium are also oftenincluded in dialysis solutions in similar concentrations as in healthyblood. The composition of a dialysis solution, and the amount ofdialysis solution used per exchange, are therefore prescribed by alicensed physician to best treat each individual patient.

The present disclosure envisions various apparatuses and methodologiesfor receiving and verifying a patient's prescription. In the embodimentsdiscussed herein, a patient can present an exchange facility 100(referring generally to each facility 100 a, 100 b, 100 c . . . 100 n,or collectively to all facilities) with a paper prescription or anelectronic file or data storage device (e.g., flash drive) that has beenprovided to the patient by a licensed physician from an outside hospitalor clinic. Facility 100 via web portal 560 (FIG. 14) or 524 (FIG. 15)can then verify the prescription by the accessing electronic medicalrecord (“EMR”) databases 522 a, 522 b and/or 522 c through the webportal. Doctor or clinician databases 522 a, 522 b and 522 c store datarelating to each patient's current dialysis prescription and mayadditionally keep historical information, such as past treatment dataand past treatment prescriptions, none, some or all of which may beaccessible via facilities 100. Thus, databases 522 a, 522 b and 522 cmay simply look (manually or automatically) at the patient'sprescription for a match with one or more current prescriptions andcommunicate back to facility 100 whether or not a match has been found.Or, databases 522 a, 522 b and 522 c may display the patient's approvedprescription(s) to the professional at facility 100 for verification.

Databases 522 a, 522 b and 522 c may additionally allow the facilityprofessional 18 to access treatment data specific for the patient. Forexample, the patient may have multiple approved prescriptions and thefreedom to pick any prescription to use on a given day. Patient data mayindicate that one prescription may be working better than one or moreother prescription. The facility professional 18 may be trained to lookat the data and recommend one or more of the patient's better performingtreatments for that day.

It is also contemplated to not require the patient to have to bring thepatient's prescription to facility 100. Instead, patient name and/orpatient identification is/are entered at facility 100, whichcommunicates over web portal 524 or 560 with a database 522 a, 522 b and522 c, which in turn communicates back the patient's currently approvedprescription(s) if it exists. Here, verification exists but no matchingis required.

If the patient cannot be found on a database 522 a, 522 b or 522 c, itis contemplated to let the facility professional 18 contact thepatient's doctor or clinician to gain authorization to let the patientperform an exchange. And as discussed above, certain countries or areasof countries may not have the ability to link to a system forverification. It is accordingly contemplated to allow the prescriptionbrought on paper or electronically to be self-authenticating, so that anexchange may take place as long as the prescription appears to belegitimate. Here again, when a patient visits a facility 100 for thefirst time, the patient and his/her current prescription can be enteredinto the local facility 100 computers to enable verification to beperformed the next time the patient returns to facility 100. If thepatient's prescription is changed, the change can be noted on thecomputers of local facility 100.

As discussed in detail below, after the prescription is verifiedaccording to any of the embodiments discussed above, or is taken asself-authenticating, the prescription is used to determine the volumeand type of dialysis solution that the patient needs for the presenttreatment. The prescription also indicates whether the dialysis solutionis to be delivered to the patient via a machine or is to be deliveredmanually. Knowing this information, the patient can proceed to the nextstep towards obtaining treatment.

In the illustrated embodiments, system hub 520 is connected to aconnectivity server 530, a service portal 540 and web portals 560 and/or524. System hub 520 communicates with the patients' home peritonealdialysis or APD machines 550 through connectivity server 530 to downloadnew treatment prescriptions to home machines 550 and to receive currenttreatment data from the home APD machines 550. In the illustratedembodiment, machine 550 is a hub for peritoneal dialysis peripherals atthe patient's home (indicated by the dotted lines in FIGS. 14 and 15),which can include for example: a modem 552, a blood pressure monitor554, a scale 556, and a user interface, such as a wireless tablet userinterface 558. The modem 552, blood pressure monitor 554, scale 556 andtablet 558 may communicate wirelessly with home APD machine 550, or inthe alternative may be wired to home machine 550.

Modem 552 can be a 3G, 4G, 5G or other type of Internet modem forenabling communication between home machines 550 and system hub 520.Blood pressure monitor 554 and scale 556 enable patient blood pressureand weight to be taken and recorded. Likewise, blood pressure monitor554 may be a pneumatically controlled blood pressure cuff that ispressurized around the patient's arm. Blood pressure monitor 554 cansend blood pressure data to the control processor of home machine 550,or the patient can measure his or her own blood pressure and enter thatdata into tablet 558, which in turn communicates the blood pressure datawith the control processor of home machine 550. The control processor ofhome APD machine 550 can use weight data from scale 556, for example, tocalculate how much ultrafiltration has been removed from the patientafter a treatment. Treatment data is stored and later transferred viamodem 552 to an electronic medical records database 522 a to 522 c touse in evaluating a current treatment prescription and for determiningnew prescriptions.

Besides storing weight and blood pressure data, each home peritonealdialysis treatment performed by a patient using home machine 550 resultsin the storage of data relating to the parameters and activities of homemachine 550 and the patient over the course of the treatment. Machine550 can store, for example, dialysis fluid flowrates, and the totalamount of ultrafiltrate removed over treatment. Errors, alerts, alarmconditions and whether or not treatment steps have been successfullyperformed can also be recorded. Treatment data is then sent from homemachine 550 via modem 552 to system hub 520 via connectivity server 530,where it is stored in the hospital or clinician databases 522 a, 522 bor 522 c, which can then be accessed by facilities 100 a, 100 b or 100 cas discussed above.

Doctor and clinician databases 522 a, 522 b and 522 c containpatient-specific treatment and prescription data and therefore access tothe databases can be highly restricted. In each of the embodiments shownin FIGS. 14 and 15, facilities 100 a, 100 b and 100 c may be able togain some level of access to doctor or clinician databases 522 a, 522 band 522 c through a web portal. In FIG. 14, facilities 100 a, 100 b and100 c along with patients and clinicians 562 a, 562 b and 562 c, e.g.,from their home computers, each access web portal 560 hosted by themachine supplier. The doctors/clinicians will have access to data thatcannot be obtained by the patients or the public at large however.Facilities 100 a, 100 b and 100 c may have the doctors/clinician levelof access, the public at large level of access or some level of accessin between. In FIG. 15, the same level of access to the patientdatabases provided by the machine supplier portal 560 in FIG. 14 may beafforded to facilities 100 a, 100 b and 100 c via doctor/clinicianInternet portal 524. Again in FIG. 15, doctor/clinician portal 524 andfacilities 100 a, 100 b and 100 c are managed and/or owned by a clinicor hospital. In FIG. 14, portal 560 and facilities 100 a, 100 b and 100c are managed and/or owned instead by the machine supplier.

Referring again to both FIGS. 14 and 15, system hub 520 and connectivityserver 530 are also connected to service portal 540. Connectivity server530 allows a service personnel director 542 and service personnel 544 a,544 b and 544 c to track and retrieve various assets across the networkusing home machine 550 and/or modem serial numbers. The assets mayinclude APD machines and/or other equipment located inside facilities100 a, 100 b and 100 c. The connectivity server 530 can also be used toreceive and provide firmware upgrades to the APD machines located at thepatients' homes or the in-center APD machines located inside facilities100 a, 100 b and 100 c. The APD machines and/or other equipment locatedanywhere on system 10, 110, including inside facilities 100 a, 100 b and100 c, may also be operated in a service mode for service personnel toaccess, diagnose and troubleshoot onsite and/or remotely. A servicetechnician can also remotely investigate and retrieve the data filesstored on the APD machines and/or other equipment, located anywhere onsystem 10, 110, including inside facilities 100 a, 100 b and 100 c, todetermine a cause of machine error.

While systems 10 and 110 assume that the patients have home dialysismachines 550 and Internet access to portals 524 and 560, it is alsoenvisioned that the present disclosure could be used in developingcountries and other areas in which people need access to renal therapybut do not have access to or the means for home APD machine 550 or theInternet. Systems 10 and 110 therefore also include and support walk-uppatients located in areas that do not have home dialysis equipment,service personnel support, system hub support, or access to a webportal. A facility 100 here instead provides a computer and software foraccepting and verifying a customer and/or a prescription.

For example, if a patient presents a facility 100 with a paperprescription, the facility can place a call to the prescribingphysician's hospital or clinic to verify the prescription provided bythe patient. A licensed physician can also contact the facility 100directly on behalf of a patient and provide a prescription prior to thepatient's visit to the facility to expedite treatment. If a prescriptionis written by a hospital or clinic associated with the facility 100, thefacility may already have access to the patient's records upon thepatient's arrival at the facility. Those of ordinary skill in the artwill understand that there are additional methods of receiving apatient's prescription that could be utilized by a facility, e.g., in adeveloping country, according to the present disclosure.

In some cases, such as when a prescription is provided directly to thefacility by a licensed physician or when the prescription is prescribedby a hospital or clinic associated with the facility, the facility canverify the prescription simultaneously with the reception of theprescription. In other cases, such as when patients produce theprescriptions themselves at the facility 100, the verification processoccurs after the facility receives the prescription. In the case ofrepeat patients at the facility, the facility may be able to keep apatient's prescription on electronic or paper file and recall theprescription each time the patient enters the facility for treatmentafter the prescription has been verified during an initial visit.

After facility 100 has verified the patient's prescription, the facilityknows the type and amount of dialysis solution as well as any disposableitems needed for same. Each facility 100 therefore stores a plurality ofperitoneal dialysis solutions of varying chemical concentrations andassociated disposables to meet the needs of different patients, havingdifferent residual renal function and toxin transport characteristics.Dispensing the specific amount of the prescribed dialysis solution foreach patient can be accomplished in a number of ways, several of whichare described below.

Additional Aspects of the Present Disclosure

Aspects of the subject matter described herein may be useful alone or incombination with any one or more of the other aspect described herein.Without limiting the foregoing description, in a first aspect of thepresent disclosure, a method of treating peritoneal dialysis patientsincludes: providing a plurality of different peritoneal dialysissolutions at a single location; accepting a patient at the singlelocation; receiving a prescription for the patient; selecting one of theperitoneal dialysis solutions based on the prescription; and enablingthe patient to undergo a peritoneal dialysis treatment using theselected peritoneal dialysis solution.

In accordance with a second aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, the receiving includes accepting the prescription.

In accordance with a third aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, the receiving includes recalling the prescription.

In accordance with a fourth aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, the receiving includes verifying the prescription.

In accordance with a fifth aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, the enabling includes providing the patient with aperitoneal dialysis machine and a cassette.

In accordance with a sixth aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, the enabling includes providing a continuous ambulatoryperitoneal dialysis catheter.

In accordance with a seventh aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, the enabling includes providing access to amulti-treatment container of the selected peritoneal dialysis solution.

In accordance with an eighth aspect of the present disclosure, which maybe used in combination with the seventh aspect and any other aspect orcombination of aspects listed herein, the enabling includes metering anamount of the selected peritoneal dialysis solution to the patient, theamount specified by the prescription.

In accordance with a ninth aspect of the present disclosure, which maybe used in combination with the eighth aspect any other aspect orcombination of aspects listed herein, the selected peritoneal dialysissolution is provided in a container and in a volume according to thepatient.

In accordance with a tenth aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, the enabling includes allowing the patient to manuallydrain spent dialysis fluid.

In accordance with an eleventh aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, a method of enabling peritoneal dialysis formultiple persons in a single location includes: providing multipledialysis solutions of varying concentrations at the single location;accepting a person who is a peritoneal dialysis patient at a clinic orhospital that is different from the location; and matching the person toone of the peritoneal dialysis solutions, wherein the person may thenuse the matched peritoneal dialysis solution in a peritoneal dialysistreatment.

In accordance with a twelfth aspect of the present disclosure, which maybe used in combination with the eleventh aspect and any other aspect orcombination of aspects listed herein, the person is verified byaccessing information provided by the clinic or hospital.

In accordance with a thirteenth aspect of the present disclosure, whichmay be used in combination with the eleventh aspect any other aspect orcombination of aspects listed herein, the peritoneal dialysis solutionis matched based on a prescription provided by the clinic or hospital.

In accordance with a fourteenth aspect of the present disclosure, whichmay be used in combination with the eleventh aspect any other aspect orcombination of aspects listed herein, accepting the person includesentering information provided by the person and obtaining the matchedperitoneal dialysis solution based on the entered information.

In accordance with an fifteenth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, a method of enabling peritoneal dialysisself-treatment for multiple persons in a single location includes:providing a plurality of peritoneal dialysis machines capable ofdispensing dialysis solutions of varying concentrations; and matching aperson to a dialysis solution based on a prescription provided by theperson, wherein the person may then use one of the peritoneal dialysismachines to perform a peritoneal dialysis treatment.

In accordance with a sixteenth aspect of the present disclosure, whichmay be used in combination with the fifteenth aspect and any otheraspect or combination of aspects listed herein, the prescription isprovided via a data storage device.

In accordance with an seventeenth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, a facility for providing peritoneal dialysisexchanges for multiple peritoneal dialysis patients includes: aplurality of peritoneal dialysis solutions of varying concentrations;and a system configured to accept information from a patient concerninga treatment prescribed for the patient, and wherein the treatmentprescribes one of the dialysis solutions and the patient can perform aperitoneal dialysis exchange at the facility using the prescribedperitoneal dialysis solution.

In accordance with an eighteenth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, a walk-in facility for peritoneal dialysispatients includes: a plurality of peritoneal dialysis machinescontaining dialysis solutions of varying concentrations; and a means ofaccepting and verifying a prescription from a patient, wherein theprescription can be matched to a dialysis solution and the patient canperform self-treatment at the facility.

In accordance with a nineteenth aspect of the present disclosure, whichmay be used in combination with the eighteenth aspect and any otheraspect or combination of aspects listed herein, the treatment isprescribed by a hospital or clinic associated with the facility.

In accordance with a twentieth aspect of the present disclosure, whichmay be used in combination with the eighteenth aspect and any otheraspect or combination of aspects listed herein, the treatment isprescribed by a hospital or clinic under different ownership than thefacility.

In accordance with a twenty-first aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, a peritoneal dialysis system includes: a reusablefill container; a reusable drain container; and a reusable continuousambulatory peritoneal dialysis (“CAPD”) set configured and arranged tobe fluidly connected to at least one of the reusable fill container orthe reusable drain container.

In accordance with a twenty-second aspect of the present disclosure,which may be used in combination with the twenty-first aspect and anyother aspect or combination of aspects listed herein, the reusable fillcontainer and the reusable drain container are configured to be matedtogether as a unit for manual transportation.

In accordance with a twenty-third aspect of the present disclosure,which may be used in combination with the twenty-first aspect and anyother aspect or combination of aspects listed herein, at least one ofthe reusable fill container and the reusable drain container is rigid orsemi-rigid.

In accordance with a twenty-fourth aspect of the present disclosure,which may be used in combination with the twenty-first aspect and anyother aspect or combination of aspects listed herein, the reusable fillcontainer or the reusable drain container includes a handle for manuallytransporting the containers when mated together to form a unit.

In accordance with a twenty-fifth aspect of the present disclosure,which may be used in combination with the twenty-first aspect and anyother aspect or combination of aspects listed herein, the reusable fillcontainer is labeled with a prescribed type of peritoneal dialysis(“PD”) solution.

In accordance with a twenty-sixth aspect of the present disclosure,which may be used in combination with the twenty-first aspect and anyother aspect or combination of aspects listed herein, the reusable fillcontainer is filled with a prescribed type of peritoneal dialysis (“PD”)solution.

In accordance with a twenty-seventh aspect of the present disclosure,which may be used in combination with the twenty-sixth aspect and anyother aspect or combination of aspects listed herein, the systemincludes a patient treatment facility, and which is configured such thatthe reusable fill container is filled with the prescribed PD solution ata location remote from the patient treatment facility.

In accordance with a twenty-eighth aspect of the present disclosure,which may be used in combination with the twenty-sixth aspect and anyother aspect or combination of aspects listed herein, the systemincludes a patient treatment facility, and which is configured such thatthe reusable fill container is filled with the prescribed PD solution atthe patient treatment facility.

In accordance with a twenty-ninth aspect of the present disclosure,which may be used in combination with the twenty-eighth aspect and anyother aspect or combination of aspects listed herein, the peritonealdialysis system of claim 7, which is configured such that the PDsolution is prepared at the treatment facility before the reusable fillcontainer is filled with the PD solution.

In accordance with a thirtieth aspect of the present disclosure, whichmay be used in combination with the twenty-eighth aspect and any otheraspect or combination of aspects listed herein, the reusable fillcontainer is provided initially with a concentrate and then mixed withpurified water at the treatment facility.

In accordance with a thirty-first aspect of the present disclosure,which may be used in combination with the twenty-eighth aspect and anyother aspect or combination of aspects listed herein, the system isconfigured such that the fill container and the PD solution aresubjected to a sterilization procedure at the patient treatment facilityprior to delivery to a patient.

In accordance with a thirty-second aspect of the present disclosure,which may be used in combination with the twenty-eighth aspect and anyother aspect or combination of aspects listed herein, the systemincludes a sterilization device at a patient treatment location of thepatient treatment facility, the fill container and the PD solutionsubjected to the sterilization device after delivery to a patient.

In accordance with a thirty-third aspect of the present disclosure,which may be used in combination with the twenty-first aspect and anyother aspect or combination of aspects listed herein, the reusable fillcontainer includes a valved pouring spout.

In accordance with a thirty-fourth aspect of the present disclosure,which may be used in combination with the twenty-first aspect and anyother aspect or combination of aspects listed herein, the reusable CAPDset is provided in a pouch, and wherein the fill or drain containerincludes structure for releasably holding the pouch.

In accordance with a thirty-fifth aspect of the present disclosure,which may be used in combination with the thirty-fourth aspect and anyother aspect or combination of aspects listed herein, the pouch isresealable.

In accordance with a thirty-sixth aspect of the present disclosure,which may be used in combination with the twenty-first aspect and anyother aspect or combination of aspects listed herein, the reusable CAPDset is provided in a pouch, and which includes a replacement patienttransfer set cap provided in the pouch.

In accordance with a thirty-seventh aspect of the present disclosure,which may be used in combination with the twenty-first aspect and anyother aspect or combination of aspects listed herein, the reusable CAPDset includes a fill line and a drain line in fluid communication with apatient line.

In accordance with a thirty-eighth aspect of the present disclosure,which may be used in combination with the twenty-first aspect and anyother aspect or combination of aspects listed herein, the CAPD setincludes a manual valve that the user can manipulate to switch from adrain mode, to a flush mode, to a fill mode.

In accordance with a thirty-ninth aspect of the present disclosure,which may be used in combination with the twenty-first aspect and anyother aspect or combination of aspects listed herein, the system isconfigured such that three caps from the CAPD set, one cap from the fillcontainer, one cap from the drain container, and one cap from the pouchare subjected to a sterilization process after treatment.

In accordance with a fortieth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, a peritoneal dialysis system includes: a reusablefill container; and a reusable drain container, wherein the reusablefill container and the reusable drain container are configured to bemated together as a unit for manual transportation.

In accordance with a forty-first aspect of the present disclosure, whichmay be used in combination with the fortieth aspect and any other aspector combination of aspects listed herein, the disposable CAPD set isprovided in a disposable pouch subjected to a sterilization process.

In accordance with a forty-second aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, a peritoneal dialysis system includes: a fillcontainer; and an energizing unit that removably accepts the fillcontainer, the energizing unit including a sterilization source soconfigured and arranged relative to the fill container when accepted bythe energizing unit to place fluid within the fill container in aphysiologically safe condition for delivery to the peritoneal cavity ofa patient.

In accordance with a forty-third aspect of the present disclosure, whichmay be used in combination with the forty-second aspect and any otheraspect or combination of aspects listed herein, the fluid is water ordialysate.

In accordance with a forty-fourth aspect of the present disclosure,which may be used in combination with the forty-second aspect and anyother aspect or combination of aspects listed herein, the fluid iswater, and which includes a packet of additives which when mixed withthe water form dialysate suitable for delivery to the peritoneal cavityof the patient.

In accordance with a forty-fifth aspect of the present disclosure, whichmay be used in combination with the forty-fourth aspect and any otheraspect or combination of aspects listed herein, the fill containerprovides an opening to receive the additives from the packet.

In accordance with a forty-sixth aspect of the present disclosure, whichmay be used in combination with the forty-second aspect and any otheraspect or combination of aspects listed herein, the sterilizing sourceincludes a plurality of ultraviolet (“UV”) lights.

In accordance with a forty-seventh aspect of the present disclosure,which may be used in combination with the forty-second aspect and anyother aspect or combination of aspects listed herein, the sterilizingsource includes a plurality of panels arranged to be adjacent to aplurality of sides of the fill container when accepted by the energizingunit.

In accordance with a forty-eighth aspect of the present disclosure,which may be used in combination with the forty-second aspect and anyother aspect or combination of aspects listed herein, the energizingunit includes a measurement device for determining how much fluid hasbeen delivered to the container.

In accordance with a forty-ninth aspect of the present disclosure, whichmay be used in combination with the forty-eighth aspect and any otheraspect or combination of aspects listed herein, the measurement deviceincludes a weigh scale.

In accordance with a fiftieth aspect of the present disclosure, whichmay be used in combination with the forty-second aspect and any otheraspect or combination of aspects listed herein, the energizing unitincludes a heater positioned and arranged to heat fluid within the fillcontainer when accepted by the energizing unit.

In accordance with a fifty-first aspect of the present disclosure, whichmay be used in combination with the forty-second aspect and any otheraspect or combination of aspects listed herein, the peritoneal dialysissystem includes at least one valve manueverably connected to theenergizing unit so as to be selectively operable with at least one of aninlet or an outlet of the fill container.

In accordance with a fifty-second aspect of the present disclosure,which may be used in combination with the fifty-first aspect and anyother aspect or combination of aspects listed herein, the fill containerincludes an inlet tube and an outlet tube, and wherein the at least onevalve includes a fill valve operable with the inlet tube and a dispensevalve operable with the outlet tube.

In accordance with a fifty-third aspect of the present disclosure, whichmay be used in combination with the forty-second aspect and any otheraspect or combination of aspects listed herein, the energizing unitincludes a control unit and at least one sensor providing feedback tothe control unit.

In accordance with a fifty-fourth aspect of the present disclosure,which may be used in combination with the fifty-third aspect and anyother aspect or combination of aspects listed herein, the at least onesensor is removably coupled to the fill container.

In accordance with a fifty-fifth aspect of the present disclosure, whichmay be used in combination with the forty-second aspect and any otheraspect or combination of aspects listed herein, the peritoneal dialysissystem includes a sterilization unit separate from the energizing unit,the sterilizing unit sized to accept a peritoneal dialysis set andconfigured to place the set into a physiologically safe condition todeliver fluid to the peritoneal cavity of the patient.

In accordance with a fifty-sixth aspect of the present disclosure, whichmay be used in combination with the fifty-fifth aspect and any otheraspect or combination of aspects listed herein, the sterilizing unitused ultraviolet (“UV”) radiation to place the peritoneal dialysis setinto the physiologically safe condition.

In accordance with a fifty-seventh aspect of the present disclosure,which may be used in combination with the fifty-fifth aspect and anyother aspect or combination of aspects listed herein, the peritonealdialysis system includes a disinfection unit separate from theenergizing unit and the sterilization unit, the disinfection unitconfigured to disinfect the peritoneal dialysis set prior to placing theset into the physiologically safe condition using the sterilizing unit.

In accordance with a fifty-eighth aspect of the present disclosure,which may be used in combination with the fifty-seventh aspect and anyother aspect or combination of aspects listed herein, the disinfectionunit is a hot water disinfection unit.

In accordance with a fifty-ninth aspect of the present disclosure, whichmay be used in combination with the forty-second aspect and any otheraspect or combination of aspects listed herein, the peritoneal dialysissystem includes a fluid purification unit separate from the energizingunit for purifying the fluid prior to placing the fluid into thephysiologically safe condition using the energizing unit.

In accordance with a sixtieth aspect of the present disclosure, whichmay be used in combination with the fifty-ninth aspect and any otheraspect or combination of aspects listed herein, the fluid purificationunit uses at least one process selected from the group consisting of:distillation, reverse osmosis, carbon filtering, ultraviolet (“UV”)radiation, electro-deionization, ultrafiltering or any combinationthereof.

In accordance with a sixty-first aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, a peritoneal dialysis (“PD”) method includes:providing a dialysate additive packet, a disinfected PD set and a draincontainer to a patient; at a patient station, providing a sterilizingunit and an energizing unit housing a fill container; enabling thepatient to place the disinfected PD set into the sterilizing unit;causing the sterilizing unit to place the disinfected PD set into aphysiologically safe condition for use with the patient; enabling thepatient to empty the contents of the additive packet into the fillcontainer housed by the energizing unit; causing the fill container tofill with purified water and mix the additive contents with the purifiedwater to form PD dialysate; enabling the patient to drain effluent fluidto the drain container using the physiologically safe PD set; heatingand sterilizing the PD dialysate to form a physiologically safe andproperly heated dialysate; and when the effluent fluid drain iscompleted and the dialysate is physiologically safe and properly heated,filling the patient from the fill container, through the PD set with thephysiologically safe and properly heated dialysate.

In accordance with a sixty-second aspect of the present disclosure,which may be used in combination with the sixty-first aspect and anyother aspect or combination of aspects listed herein, the PD methodincludes weighing an amount of effluent fluid drained to the draincontainer.

In accordance with a sixty-third aspect of the present disclosure, whichmay be used in combination with the sixty-second aspect and any otheraspect or combination of aspects listed herein, the PD method includesweighing an amount of physiologically safe and properly heated dialysatedelivered to the patient and subtracting the delivered amount from thedrained amount to determine an amount of ultrafiltration (“UF”) removedfrom the patient.

In accordance with a sixty-fourth aspect of the present disclosure,which may be used in combination with the sixty-first aspect and anyother aspect or combination of aspects listed herein, the PD methodincludes enabling the patient to return the used PD set and filled draincontainer for refurbishment.

In accordance with a sixty-fifth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, a peritoneal dialysis (“PD”) system includes: aperitoneal dialysis set provided to a patient; a disinfection unitconfigured to disinfect the peritoneal dialysis set prior to providingthe set to the patient; a sterilization unit sized to accept theperitoneal dialysis set and configured to place the set into aphysiologically safe condition to deliver fluid to the peritoneal cavityof the patient; a fill container; and an energizing unit that removablyaccepts the fill container, the energizing unit including asterilization source so configured and arranged relative to the fillcontainer when accepted by the energizing unit to place fluid within thefill container in a physiologically safe condition for delivery to theperitoneal cavity of a patient.

In accordance with a sixty-sixth aspect of the present disclosure, whichmay be used in combination with the sixty-fifth aspect and any otheraspect or combination of aspects listed herein, the system is providedwithin a single facility.

In accordance with a sixty-seventh aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, a peritoneal dialysis method includes: providinga reusable fill container, a reusable drain container, and a reusablecontinuous ambulatory peritoneal dialysis (“CAPD”) set to a patient;enabling the patient to perform a CAPD treatment using the fillcontainer, drain container, and CAPD set; receiving the fill container,drain container, and CAPD set back from the patient after the CAPDtreatment; and refurbishing the fill container, drain container, andCAPD set for use with a subsequent CAPD treatment.

In accordance with a sixty-eighth aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIGS. 1 to 15 may be used in combination with any one ormore or all of the preceding aspects.

The invention claimed is:
 1. A peritoneal dialysis system comprising: afill container; an energizing unit that removably accepts the fillcontainer, the energizing unit including a sterilization source soconfigured and arranged relative to the fill container when accepted bythe energizing unit to place fluid while residing within the fillcontainer in a physiologically safe condition for delivery to theperitoneal cavity of a patient through an indwelling catheter; a fillline at a first end extending directly from the fill container, andwherein a second end of the fill line is placed in fluid communicationwith the patient's indwelling catheter without the fill line passingthrough any intervening sterilization or electromechanical equipmentbetween the first end of the fill line and the patient's indwellingcatheter; a measurement device configured to sense an amount of fluiddelivered to the fill container while the fill container is accepted bythe energizing unit; and a control unit operable with the measurementdevice to (i) stop fluid delivery when the amount of the fluid deliveredto the fill container reaches a threshold, and (ii) during deliveryand/or after delivery, activate the sterilizing source to place thefluid residing in the fill container in the physiologically safecondition.
 2. The peritoneal dialysis system of claim 1, wherein thefluid is water or dialysate.
 3. The peritoneal dialysis system of claim1, wherein the fluid is water, and which includes a packet of additiveswhich when mixed with the water form dialysate suitable for delivery tothe peritoneal cavity of the patient.
 4. The peritoneal dialysis systemof claim 3, wherein the fill container provides an opening to receivethe additives from the packet.
 5. The peritoneal dialysis system ofclaim 1, wherein the sterilization source includes a plurality ofultraviolet (“UV”) lights.
 6. The peritoneal dialysis system of claim 1,wherein the sterilization source includes a plurality of panels arrangedto be adjacent to a plurality of sides of the fill container whenaccepted by the energizing unit.
 7. The peritoneal dialysis system ofclaim 1, wherein the threshold is based on a prescribed fill volume forthe patient.
 8. The peritoneal dialysis system of claim 1, wherein themeasurement device includes a weigh scale.
 9. The peritoneal dialysissystem of claim 1, wherein the energizing unit includes a heaterpositioned and arranged to heat fluid within the fill container whenaccepted by the energizing unit.
 10. The peritoneal dialysis system ofclaim 1, which includes at least one valve manueverably connected to theenergizing unit so as to be selectively operable with at least one of aninlet or an outlet of the fill container.
 11. The peritoneal dialysissystem of claim 10, wherein the fill container includes an inlet tubeand an outlet tube, and wherein the at least one valve includes a fillvalve operable with the inlet tube and a dispense valve operable withthe outlet tube.
 12. The peritoneal dialysis system of claim 1, whereinthe energizing unit includes at least one sensor providing feedback tothe control unit.
 13. The peritoneal dialysis system of claim 12,wherein the at least one sensor is removably coupled to the fillcontainer.
 14. The peritoneal dialysis system of claim 1, which includesa sterilization unit separate from the energizing unit, thesterilization unit sized to accept a peritoneal dialysis set andconfigured to place the set into a physiologically safe condition todeliver fluid to the peritoneal cavity of the patient.
 15. Theperitoneal dialysis system of claim 14, wherein the sterilization unituses ultraviolet (“UV”) radiation to place the peritoneal dialysis setinto the physiologically safe condition.
 16. The peritoneal dialysissystem of claim 14, which includes a disinfection unit separate from theenergizing unit and the sterilization unit, the disinfection unitconfigured to disinfect the peritoneal dialysis set prior to placing theset into the physiologically safe condition using the sterilizationunit.
 17. The peritoneal dialysis system of claim 16, wherein thedisinfection unit is a hot water disinfection unit.
 18. The peritonealdialysis system of claim 1, which includes a fluid purification unitseparate from the energizing unit for purifying the fluid prior toplacing the fluid into the physiologically safe condition using theenergizing unit.
 19. The peritoneal dialysis system of claim 18, whereinthe fluid purification unit uses at least one process selected from thegroup consisting of: distillation, reverse osmosis, carbon filtering,ultraviolet (“UV”) radiation, electro-dionization, ultrafiltering or anycombination thereof.
 20. A peritoneal dialysis system comprising: aperitoneal dialysis set provided to a patient; a disinfection unitconfigured to disinfect the peritoneal dialysis set prior to providingthe set to the patient; a sterilization unit sized to accept theperitoneal dialysis set and configured to place the set into aphysiologically safe condition to deliver fluid to the peritoneal cavityof the patient through an indwelling catheter; a fill container; a fillline at a first end extending directly from the fill container, andwherein a second end of the fill line is placed in fluid communicationwith the patient's indwelling catheter without the fill line passingthrough any intervening sterilization or electromechanical equipmentbetween the first end of the fill line and the patient's indwellingcatheter; an energizing unit that removably accepts the fill container,the energizing unit including a sterilization source so configured andarranged relative to the fill container when accepted by the energizingunit to place fluid within the fill container in a physiologically safecondition for delivery to the peritoneal cavity of a patient; ameasurement device configured to sense an amount of fluid delivered tothe fill container while the fill container is accepted by theenergizing unit; and a control unit operable with the measurement deviceto (i) stop fluid delivery when the amount of the fluid delivered to thefill container reaches a threshold, and (ii) during delivery and/orafter delivery, activate the sterilizing source to place the fluidresiding in the fill container in the physiologically safe condition.21. The peritoneal dialysis system of claim 20, which is provided withina single facility.
 22. The peritoneal dialysis system of claim 1, whichincludes (i) an inlet tube enabling the fill container to be filled withthe fluid while removably accepted by the energizing unit, and (ii) anoutlet tube enabling the fluid to be delivered to the patient after thefluid is placed in the physiologically safe condition.
 23. A peritonealdialysis system comprising: a fill container; an energizing unit thatremovably accepts the fill container, the energizing unit including asterilization source other than a heating source, the sterilizationsource configured and arranged relative to the fill container whenaccepted by the energizing unit to place fluid while residing within thefill container in a physiologically safe condition for delivery to theperitoneal cavity of a patient through an indwelling catheter; a fillline at a first end extending directly from the fill container, andwherein a second end of the fill line is placed in fluid communicationwith the patient's indwelling catheter without the fill line passingthrough any intervening sterilization or electromechanical equipmentbetween the first end of the fill line and the patient's indwellingcatheter; a measurement device configured to sense an amount of fluiddelivered to the fill container while the fill container is accepted bythe energizing unit; and a control unit operable with the measurementdevice to (i) stop fluid delivery when the amount of the fluid deliveredto the fill container reaches a threshold, and (ii) during deliveryand/or after delivery, activate the sterilizing source to place thefluid residing in the fill container in the physiologically safecondition.
 24. A peritoneal dialysis system comprising: a fillcontainer; an energizing unit that removably accepts the fill container,the energizing unit including a heater and a sterilization sourceseparate from the heater, wherein the sterilization source is configuredand arranged relative to the fill container when accepted by theenergizing unit to place fluid while residing within the fill containerin a physiologically safe condition for delivery to the peritonealcavity of a patient through an indwelling catheter, and wherein thephysiologically safe condition includes the fluid being heated to adesired body temperature; a fill line at a first end extending directlyfrom the fill container, and wherein a second end of the fill line isplaced in fluid communication with the patient's indwelling catheterwithout the fill line passing through any intervening sterilization orelectromechanical equipment between the first end of the fill line andthe patient's indwelling catheter; a measurement device configured tosense an amount of fluid delivered to the fill container while the fillcontainer is accepted by the energizing unit; and a control unitoperable with the measurement device to (i) stop fluid delivery when theamount of the fluid delivered to the fill container reaches a threshold,and (ii) during delivery and/or after delivery, activate the sterilizingsource to place the fluid residing in the fill container in thephysiologically safe condition.
 25. A peritoneal dialysis systemcomprising: a peritoneal dialysis set provided to a patient; adisinfection unit configured to disinfect the peritoneal dialysis setprior to providing the set to the patient; a sterilization unit sized toaccept the peritoneal dialysis set and configured to place the set intoa physiologically safe condition to deliver fluid to the peritonealcavity of the patient through an indwelling catheter; a fill container;a fill line at a first end extending directly from the fill container,and wherein a second end of the fill line is placed in fluidcommunication with the patient's indwelling catheter without the fillline passing through any intervening sterilization or electromechanicalequipment between the first end of the fill line and the patient'sindwelling catheter; an energizing unit that removably accepts the fillcontainer, the energizing unit including a heater and a sterilizationsource separate from the heater, wherein the sterilization source isconfigured and arranged relative to the fill container when accepted bythe energizing unit to place fluid within the fill container in aphysiologically safe condition for delivery to the peritoneal cavity ofa patient, and wherein the heater is positioned and arranged to heatfluid within the fill container when accepted by the energizing unit; ameasurement device configured to sense an amount of fluid delivered tothe fill container while the fill container is accepted by theenergizing unit; and a control unit operable with the measurement deviceto (i) stop fluid delivery when the amount of the fluid delivered to thefill container reaches a threshold, and (ii) during delivery and/orafter delivery, activate the sterilizing source to place the fluidresiding in the fill container in the physiologically safe condition.